ELIQUENT LIFE SCIENCES ANNOUNCES ACQUISITION OF EUROPEAN-FOCUSED REGULATORY PARTNER: RApport Global Strategic Services

ELIQUENT Life Sciences (ELIQUENT), a global regulatory consulting firm for the life sciences industry, today announced the acquisition of RApport Global Strategic Services (RApport). RApport is a UK based international regulatory consultancy supporting life science innovators gaining and maintaining authorization for products worldwide. ELIQUENT’s acquisition of RApport represents an important step in company’s international growth and expanded European capabilities.

RApport’s European expertise expands ELIQUENT’s geographic reach and delivers a dynamic portfolio of global regulatory consulting services. The combined capabilities of ELIQUENT and RApport enable end-to-end regulatory solutions designed to streamline development, market entry, and compliance strategies across global markets.

“Today’s announcement further positions ELIQUENT as a leader in global regulatory consulting and underscores our commitment to delivering value to our clients,” said Tim Dietlin, Chief Executive Officer of ELIQUENT Life Sciences. “I look forward to partnering with the talented RApport team as we offer our clients an expanded portfolio of solutions designed to streamline market entry and compliance strategies worldwide.”

“As RApport integrates with ELIQUENT, we are forging a powerful synergy in the global regulatory arena, blending our European expertise with ELIQUENT’s extensive US and Asia Pacific capabilities” added Iftikhar Saiyed, Co-Chief Executive Officer of Rapport. Lorna Griffin, Co-Chief Executive Officer of Rapport, further added, “This partnership expands our ability to provide comprehensive regulatory solutions to the life sciences industry.”

RApport was advised by BDO LLP and Simons Muirhead Burton LLP, with supplemental strategic counsel from Indus Valley Advisors. ELIQUENT and GHO Capital were advised by Slaughter and May, and Deloitte LLP.

About RApport
RApport Global Strategic Services is a specialist international regulatory consultancy providing regulatory support to the pharmaceutical, biotechnological, and medical device industries. The RApport team includes highly experienced regulatory experts with extensive knowledge of global regulatory pathways. The company’s global solutions include strategic and technical guidance across development programs, regulatory submissions, post-market support and beyond.

About ELIQUENT
ELIQUENT Life Sciences is the fusion of five global regulatory consultancies: Validant, Greenleaf Health, DataRevive, Oriel Stat-a-Matrix, and IDEC. This unprecedented assembly of regulatory leaders, industry experts, and technical specialists facilitates comprehensive services that support pharmaceutical, biotechnology, and medical device companies navigating the complex regulatory landscape.

ELIQUENT’s accelerated growth strategy is supported by GHO Capital, the European specialist investor in healthcare. Having partnered with ELIQUENT Life Sciences (formerly Validant) since December 2018, today’s announcement follows the acquisition of DataRevive in 2019, a regulatory strategy and consultancy for global clients; November 2020 acquisition of IDEC, a leading regulatory consultancy in Japan; December 2020 acquisition of Oriel STAT A MATRIX, a global consultancy and training firm for the medical device industry; and April 2021 acquisition of Greenleaf Health, a leading FDA regulatory consulting firm.

About GHO
Global Healthcare Opportunities, or GHO Capital Partners LLP, is a leading specialist healthcare investment advisor based in London. We apply global capabilities and perspectives to unlock high growth healthcare opportunities, targeting Pan-European and transatlantic internationalisation to build market leading businesses of strategic global value. Our proven investment track record reflects the unrivaled depth of our industry expertise and network. We partner with strong management teams to generate long-term sustainable value, improving the efficiency of healthcare delivery to enable better, faster, more accessible healthcare. For further information, please visit www.ghocapital.com.

Strategic Repositioning Creates Unprecedented Assembly of Regulatory Expertise & Global Capabilities

The Validant Group of companies today announced a strategic repositioning that unites the five companies as one global regulatory brand: ELIQUENT Life Sciences.

ELIQUENT Life Sciences is the fusion of five global regulatory consultancies: Validant, Greenleaf Health, DataRevive, Oriel Stat-a-Matrix, and IDEC. The collective capabilities of this unmatched alliance enable integrated solutions that bridge the spectrum of regulatory challenges. ELIQUENT Life Sciences delivers comprehensive services that support pharmaceutical, biotechnology, and medical device companies navigating the complex regulatory landscape.

“ELIQUENT Life Sciences is an unprecedented assembly of regulatory leaders, industry experts, and technical specialists. Our combined capabilities deliver the best path forward for global life science innovators. Together, ELIQUENT sets a new standard for regulatory excellence,” said Tim Dietlin, Chief Executive Officer, ELIQUENT Life Sciences.

The ELIQUENT team works cross-functionally to deliver solutions that global life science innovators need to gain and maintain authorization for the products. Guided by decades of regulatory and clinical experience, ELIQUENT’s team of life science experts have the specialized skills to assist clients across therapeutic modalities, phase-based pathways, and major global markets.

The combined achievements and substantial qualifications of the ELIQUENT team enable a full-service engagement that delivers end-to-end support in the following areas:

Regulatory Affairs Solutions

From the earliest phases of development, through regulatory submissions, to post-approval support, ELIQUENT’s robust blend of technical skill and clinical expertise guide companies to approval and beyond.

Pharmacovigilance & Post-Market Surveillance Solutions

With an approach that includes both strategic direction and hands-on global support, ELIQUENT’s customized pharmacovigilance services empower companies to operate with confidence.

Quality & Compliance Solutions

ELIQUENT’s highly specialized compliance experts build customized solutions that equip companies with best-in-class strategic support, technical guidance, and project-based achievements.

Remediation Solutions

ELIQUENT’s team of respected professionals, along with a network of ready to deploy global experts, bring an unrivaled level of credibility and trust when interacting with regulators and guiding companies to remediation success.

Expert Training

ELIQUENT’s customizable training programs provide in-person and remote training services to empower both leadership teams and employees with the _skills and tools to create pragmatic problem-solving processes and maintain adherence to evolving regulatory, compliance, and quality standards.

The strategic repositioning of ELIQUENT Life Sciences is supported by GHO Capital, the European specialist investor in healthcare. Having partnered with Validant since December 2018, today’s announcement follows the acquisition of DataRevive in 2019, a regulatory strategy and consultancy for global clients; November 2020 acquisition of IDEC, a leading regulatory consultancy in Japan; December 2020 acquisition of Oriel STAT A MATRIX, a global consultancy and training firm for the medical device industry; and April 2021 acquisition of Greenleaf Health, a leading FDA regulatory consulting firm.

About GHO Capital
Global Healthcare Opportunities, or GHO Capital Partners LLP, is a leading specialist healthcare investment advisor based in London. We apply global capabilities and perspectives to unlock high growth healthcare opportunities, targeting Pan-European and transatlantic internationalisation to build market leading businesses of strategic global value. Our proven investment track record reflects the unrivalled depth of our industry expertise and network. We partner with strong management teams to generate long-term sustainable value, improving the efficiency of healthcare delivery to enable better, faster, more accessible healthcare. For further information, please visit www.ghocapital.com.

Learn more at ELIQUENT.com

Greenleaf Health, Inc. (Greenleaf), a leading consulting firm for companies regulated by the Food and Drug Administration (FDA), is pleased to announce that Sarah McGarry, M.D., has joined as Senior Vice President, Drug and Biological Products. Throughout her 18-year FDA service, Sarah held multiple leadership, review, and advisory positions within the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). Her knowledge of the FDA review process and regulatory policy will enrich the strategic and scientific guidance that Greenleaf provides to clients.  

As an infectious disease specialist, Sarah dedicated much of her career to CDER’s antivirals division, where she played a significant role in the approvals of important new antiviral products, including the first-in-class HIV treatment raltegravir (as primary reviewer), the first-in-class hepatitis C treatment sofosbuvir (as team leader), and the SARS-CoV-2 treatment Paxlovid (nirmatrelvir co-packaged with ritonavir), as well as in the emergency use authorizations for anti-SARS-CoV-2 monoclonal antibody and small molecule products. Sarah was also the division’s Associate Director of Bioinformatics for three years (2017-2020), providing subject matter expertise in medical science and drug regulatory review processes and leading a multidisciplinary team within CDER responsible for modernizing the FDA’s review of marketing applications.

Her FDA experience further included serving as Acting Deputy Division Director in the epidemiology division of CBER, where she oversaw postmarket surveillance and adverse biologic reactions, as well as serving on the clinical advisors team for the Office of New Drugs (OND) policy group, where she contributed to the development of the FDA’s new drug guidance and policy.

Sarah received her M.D. from Georgetown University Medical School and completed a residency in internal medicine and a fellowship in infectious diseases at Duke University.

Learn more about Sarah McGarry.  

About Greenleaf Health

Greenleaf is guided by experts with a combined total of more than 300 years of FDA experience. Sarah McGarry joins a distinguished group of professionals at Greenleaf who previously served as leaders throughout the Agency, including: John Taylor, former FDA Counselor to the Commissioner and Principal Deputy Commissioner; Patrick Ronan, former Chief of Staff for two FDA Commissioners; Daniel Schultz, M.D., former Director of the FDA’s Center for Devices and Radiological Health (CDRH); Karen Midthun, M.D., former Director of the FDA’s Center for Biologics Evaluation and Research (CBER); John Jenkins, M.D., former Director of the Office of New Drugs for the FDA’s Center for Drug Evaluation and Research (CDER); Robert Meyer, M.D., former Director of CDER’s Office of Drug Evaluation II; Sandra Kweder, M.D., former Deputy Director of the FDA’s Europe Office and Liaison to the European Medicines Agency (EMA); Wilson Bryan, M.D., former Director of CBER’s Office of Tissues and Advanced Therapies; Chris Leptak, M.D., Ph.D., former Acting Office Director of CDER’s Office of Drug Evaluation Science; David Elder, former Director of the FDA’s Office of Regional Affairs and Office of Enforcement; Cynthia Schnedar, Director of CDER’s Office of Compliance, 2014-2016; Donald Ashley, Director of CDER’s Office of Compliance, 2017-2022; Heather Rosecrans, former Director of CDRH’s 510(k) staff; Mark Kramer, former Director of the Office of Combination Products; Joseph Griffin, former Associate Director for Policy Development, CDER Office of Medical Policy; Kalah Auchincloss, former Deputy Chief of Staff for two FDA Commissioners; Stephen Mason, former Assistant Commissioner of Legislation; Kristen Grumet, former Field Investigator for medical devices and member of the FDA Design Control Inspection Strategy (DCIS) Team; Thomas Berry, former Director of Compliance, Office of Pharmaceutical Quality Operations IV; and Grace McNally, former division director, CDER Office of Pharmaceutical Quality Policy.

Greenleaf Health provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies researching, developing, and manufacturing innovative solutions to pressing global public health challenges. Greenleaf’s combination of subject matter expertise, strategic insight, and deep institutional knowledge of the Food and Drug Administration equips clients with reliable, objective advice throughout the complex process of bringing medical products to the U.S. market.

Greenleaf Health, Inc. (Greenleaf), a leading Food and Drug Administration (FDA) regulatory consulting firm, today announces that Wilson Bryan, M.D., has joined as Executive Vice President, Drug and Biological Products. Wilson served as Director of the Office of Tissues and Advanced Therapies (OTAT) in the FDA’s Center for Biologics Evaluation and Research (CBER) from OTAT’s establishment in 2016 through February 2023, leading the FDA’s oversight of cell and gene therapies and other advanced technologies during a transformative period in their development and regulation. His experience enhances Greenleaf’s cell and gene therapy capabilities and brings added perspective to the firm’s strategic advising on drug, biologic, and medical device regulation more broadly. As a neurologist and neuromuscular specialist, Wilson deepens Greenleaf’s expertise in those fields as well.

Under Wilson’s leadership, OTAT was responsible for the regulation of gene therapies, cellular therapies, genetically-modified cells (e.g., chimeric antigen receptor T cells), tissue-engineered products, plasma protein therapeutics (e.g., immunoglobulins; coagulation factors), selected medical devices, and xenotransplantation, covering a full range of medical indications. Of the thousands of applications in the OTAT portfolio, approximately 50% were for the treatment of rare diseases. OTAT also developed processes and standards for the new Regenerative Medicine Advanced Therapy (RMAT) designation.

During his 19 years with the FDA, Wilson also served as Director of CBER’s Division of Clinical Evaluation and Pharmacology/Toxicology, Chief of the Clinical Evaluation Branch in CBER’s Office of Cellular, Tissue, and Gene Therapies (OCTGT), a clinical team leader for the Division of Neurology Products in the Center for Drug Evaluation and Research (CDER), and a medical officer in CBER.

Prior to his work at the FDA, Wilson was on the faculty of the Department of Neurology of the University of Texas Southwestern (UTSW) Medical School for 13 years. At UTSW, he served as a neuromuscular specialist and was an investigator for clinical trials in neuromuscular disorders, particularly amyotrophic lateral sclerosis (ALS), and in cerebrovascular disease. Wilson received his medical degree from the University of Chicago Pritzker School of Medicine.

Learn more about Wilson Bryan.

About Greenleaf Health

Greenleaf is guided by experts with a combined total of more than 300 years of FDA experience. Wilson Bryan joins a distinguished group of professionals at Greenleaf who previously served as leaders throughout the Agency, including: John Taylor, former FDA Counselor to the Commissioner and Principal Deputy Commissioner; Patrick Ronan, former Chief of Staff for two FDA Commissioners; Daniel Schultz, M.D., former Director of the FDA’s Center for Devices and Radiological Health (CDRH); Karen Midthun, M.D., former Director of the FDA’s Center for Biologics Evaluation and Research (CBER); John Jenkins, M.D., former Director of the Office of New Drugs for the FDA’s Center for Drug Evaluation and Research (CDER); Robert Meyer, M.D., former Director of CDER’s Office of Drug Evaluation II; Sandra Kweder, M.D., former Deputy Director of the FDA’s Europe Office and Liaison to the European Medicines Agency (EMA); Heather Rosecrans, former Director of CDRH’s 510(k) staff; David Elder, former Director of the FDA’s Office of Regional Affairs and Office of Enforcement; Cynthia Schnedar, Director of CDER’s Office of Compliance, 2014-2016; Donald Ashley, Director of CDER’s Office of Compliance, 2017-2022; Mark Kramer, former Director of the Office of Combination Products; and Chris Leptak, M.D., Ph.D., former Acting Office Director of CDER’s Office of Drug Evaluation Science.

Greenleaf Health provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies researching, developing, and manufacturing innovative solutions to pressing global public health challenges. Greenleaf’s robust blend of technical skill and FDA institutional knowledge enables the firm to provide reliable, objective guidance to companies developing medical products for the U.S. market.

Tim Dietlin Joins Validant as CEO

The Validant Group, a leading international quality, compliance, and regulatory consulting firm, today announces that Tim Dietlin has joined the company in the role of Chief Executive Officer (CEO).

“Tim brings a unique skill set to his role as CEO of the Validant Group. His deep understanding of the life sciences industry, coupled with his business effectiveness and leadership advisory experience, allows Tim to build transformative teams that drive growth and attain long-term success,” said Alistair Macdonald, Chair of the Validant Group Board of Directors and ­­Operating Partner, GHO Capital.

Tim Dietlin brings more than 25 years of leadership experience to his role as CEO of the Validant Group. Most recently, Tim served for eight years as the Global Managing Partner of the Healthcare and Life Sciences Practice at Heidrick & Struggles, a leading global executive search and management consulting firm. In this role, Tim led all aspects of the practice’s healthcare and life sciences business and specialized in providing leadership advisory services to a broad portfolio of clients, including established pharmaceutical companies, emerging high-growth biotechnology firms, and investor backed service and technology companies.

Tim’s extensive experience includes leadership roles at IBM, where he led the life sciences strategy and transformation consulting practice; INC Research, where he served as Senior Vice President of Global Consulting and Strategic Alliances; and Campbell Alliance, a life sciences management consulting firm, where Tim led the firm’s Research and Development and Medical Affairs consulting practices.

“The Validant Group has built a strong foundation as a leader in the life sciences industry. By uniting this already powerful partnership of companies, and capitalizing on our collective capabilities, we will unlock the full potential of our business,” said Tim Dietlin, Validant Group CEO. “Together, the Validant Group will deliver a full-service platform that provides unmatched regulatory clarity at every phase of the product life cycle. I look forward to cultivating and continuing to grow a united Validant Group that is stronger together and positioned for success.”

ABOUT THE VALIDANT GROUP

The Validant Group is a global, full-service life science consulting company focused on managing and resolving complex regulatory issues. The Validant Group is comprised of five companies offering collaborative consultancy services:

Validant: An international Quality, Compliance, and Regulatory consulting firm, blending industry expertise with innovation to create custom solutions for companies on the frontier of health. For further information, please visit www.validant.com

Greenleaf Health: A leading FDA regulatory consulting firm that provides best-in-class strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies regulated by the FDA. For further information, please visit www.greenleafhealth.com

Oriel Stat-A-Matrix (OSAM): A consultancy and training firm focused on medical device regulatory compliance, quality management, auditing, and training for US and international regulations. For further information, please visit www.orielstat.com

DataRevive: A global regulatory consulting company helping pharmaceutical and biotech companies with their regulatory filings. For further information, please visit www.data-revive.com

IDEC: A strategic consultancy firm providing regulatory guidance to biotechnology and pharmaceutical companies developing products for the Japanese market. For further information, please visit www.idec-inc.com

The Validant Group’s growth strategy is supported by GHO Capital Partners LLP, a leading specialist healthcare investment advisor based in London. GHO applies global capabilities and perspectives to unlock high growth healthcare opportunities in Europe, building market leading businesses of strategic global value. GHO’s proven investment track record reflects the unrivalled depth of its industry expertise and network. GHO partners with strong management teams to unlock value in a global system that demands the delivery of better, faster, more accessible healthcare. For further information, please visit www.ghocapital.com.

Sandra Kweder, M.D., former Deputy Director of FDA’s Office of New Drugs and Donald D. Ashley, J.D., former Director of CDER’s Office of Compliance, Join Firm

Greenleaf Health, Inc. (Greenleaf), a leading Food and Drug Administration (FDA) regulatory consulting firm, today announces that two former senior officials from the FDA’s Center for Drug Evaluation and Research (CDER) have joined the firm: Sandra Kweder, M.D., former Deputy Director of CDER’s Office of New Drugs (OND) and Deputy Director of the FDA’s Europe Office, as Principal, Drug and Biological Products, for Greenleaf Health; and Donald D. Ashley, J.D., former Director of CDER’s Office of Compliance, as Executive Vice President, Regulatory Compliance. Kweder and Ashley each bring unique subject matter expertise that expands Greenleaf’s unmatched regulatory advising capabilities.

Sandra Kweder, M.D.

Dr. Sandra Kweder is an internal medicine expert with more than 30 years of experience in U.S. and international medical products regulation and policy.

Prior to joining Greenleaf, Sandy served for six years as Deputy Director of the FDA’s Europe Office and Liaison to the European Medicines Agency (EMA), first in London and later in Amsterdam, working to strengthen international collaboration across all areas of FDA regulation, especially medical products. She launched new engagements with the EMA in areas including labeling and study of drugs in pregnancy, patient engagement strategy, rare disease product development, and an invigorated parallel scientific advice program. Upon returning to the U.S., she provided strategic direction and subject matter expertise to FDA leadership as Senior Medical and Regulatory Advisor in the Office of Global Strategy and Policy. 

Prior to her work in Europe, Sandy spent nearly 14 years as the Deputy Director of CDER’s Office of New Drugs. She guided OND through a phase of substantial maturation between 2002 and 2016, as the prescription drug user fee program (PDUFA) grew and CDER strengthened review standards and practices to incorporate scientific innovation and emerging drug development approaches such as patient-reported outcomes in clinical trials. She also launched and led, for 10 years, the FDA’s modernization of its approach to labeling for and studying medicines in pregnancy and lactation.

Sandy joined the FDA in 1988 as a medical officer in the Division of Antiviral Drug Products, newly established to address the urgent need for treatments for HIV/AIDS. For 33 years Sandy served in the U.S. Public Health Service, rising to the rank of Rear Admiral before retiring from the service in 2013.

As Principal, Drug and Biological Products, with Greenleaf Health, Sandy offers broad expertise accrued through multiple senior leadership roles at the FDA, where she oversaw significant regulatory developments during periods of transformation in the landscape of science policy and public health.

“It was difficult to leave FDA, so full of dynamic, intelligent, committed experts – I never had a dull moment in over 30 years. I am fortunate now, though, for an opportunity to carry that energy and integrity to Greenleaf and continue to collaborate with trusted and admired former FDA colleagues,” said Dr. Kweder.

Learn more about Dr. Kweder’s experience and her role at Greenleaf Health.

Donald D. Ashley, J.D.

Donald Ashley is an expert in compliance and enforcement matters and joins Greenleaf Health following a distinguished 25-year career at the FDA and the Department of Justice (DOJ), including six years as Director of CDER’s Office of Compliance at the FDA.

As Director of CDER’s Office of Compliance, Don led a staff of over 400 lawyers, scientists, consumer safety officers, pharmacists, and physicians. He oversaw development and implementation of the FDA’s entire breadth of drug compliance and enforcement measures, including for manufacturing quality, current good manufacturing practice, good clinical practice, data integrity, clinical trial oversight, pharmacovigilance, drug supply chain security, compounding, over-the-counter monograph compliance, drug import and export, and unapproved drug compliance, among other areas. Don led all drug compliance actions taken by the FDA following inspection, as well as all grants of regulatory discretion in drug shortage cases.

As an executive member of CDER’s Drug Risk Management Board, Don helped guide the Agency’s approach to some of most difficult drug safety issues over the last several years, including for nitrosamine and benzene impurities. In addition, Don served as one of a small group of senior agency officials who liaised with the generic drug industry to implement the Generic Drug User Fee Act program.

Before joining the FDA, Don spent nearly two decades at DOJ in both the Civil and Criminal Divisions, prosecuting violations of the Food, Drug, and Cosmetic Act among other criminal statutes, as well as managing and directing investigations on both a national and international level. Don earned his J.D. from Harvard Law School and an A.B., magna cum laude, from John Carroll University.

“I will be eternally grateful for having had the opportunity to serve with and learn from so many dedicated and talented colleagues during my 25-year career at FDA and DOJ. I’m excited to join the Greenleaf team and look forward to helping our clients navigate their most challenging regulatory, compliance, and enforcement matters,” said Don.

Learn more about Don’s experience and his role at Greenleaf Health.

About Greenleaf Health

Greenleaf is guided by experts with a combined total of more than 300 years of FDA experience. Sandy and Don join a distinguished group of professionals at Greenleaf who previously served as leaders throughout the Agency, including: John Taylor, former FDA Counselor to the Commissioner and Principal Deputy Commissioner; Dr. Daniel Schultz, former Director of the FDA’s Center for Devices and Radiological Health (CDRH); Dr. Karen Midthun, former Director of the FDA’s Center for Biologics Evaluation and Research (CBER); Dr. John Jenkins, former Director of the Office of New Drugs for the FDA’s Center for Drug Evaluation and Research (CDER); Dr. Robert Meyer, former Director of CDER’s Office of Drug Evaluation II; Heather Rosecrans, former Director of CDRH’s 510(k) staff; David Elder, former Director of the FDA’s Office of Regional Affairs and Office of Enforcement; Cynthia Schnedar, former Director of CDER’s Office of Compliance; and Mark Kramer, former Director of CDER’s Office of Combination Products.

Greenleaf Health provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies researching, developing, and manufacturing innovative solutions to pressing global public health challenges. Greenleaf’s robust blend of technical skill and FDA institutional knowledge enables the firm to provide reliable, objective guidance to companies developing medical products for the U.S. market.

Greenleaf Health, Inc. (Greenleaf), a leading Food and Drug Administration (FDA) regulatory consulting firm, today announces the firm’s complete portfolio of services to support companies developing, commercializing, utilizing, and investing in innovative digital health technologies.

“Players in the digital health space face unique challenges in navigating an ever-changing regulatory landscape, as FDA regulators try to keep up with the pace of digital health technology development,” said John Taylor, President, Greenleaf Health, and Principal, Compliance and Regulatory Affairs. “Greenleaf serves as a trusted partner to both large and small clients developing and commercializing innovative digital health technologies as they navigate the complex landscape of FDA regulations and policies.”

STRATEGIC & TECHNICAL GUIDANCE
Greenleaf professionals work as teams specializing in medical devices and combination products; product quality, manufacturing, and compliance; and drug and biological products. Greenleaf’s comprehensive approach provides a full-service engagement that ensures clients can count on expert direction as they encounter complex regulatory challenges. Greenleaf offers the following digital health-focused services:

Regulatory Strategy & Compliance
Greenleaf experts provide insight, clarity, and strategic consultation on digital health topics. Regulatory strategy and compliance services include:

• Advise clients on FDA regulatory policies, programs, and procedures, including questions related to jurisdiction to regulate, device classification, and potential pathways to market 
• Partner with clients to design strategies for product development and premarket review
• Assist with marketing application preparation and submission
• Provide advice regarding FDA communications, including compliance and regulatory correspondence
• Advise on FDA labeling and postmarket safety requirements

Advisory Services
Greenleaf professionals assist entities involved in digital health technology investments and transactions. Advisory services include:

• Perform due diligence and regulatory risk assessments of potential targets
• Advise investors on opportunities to manage and mitigate risks in order to achieve desired regulatory outcomes
• Research and analyze regulatory data sources

Regulatory Policy
Greenleaf’s cross-functional teams help clients keep pace with developments and navigate the emerging regulatory landscape. Regulatory policy services include:

• Identify novel regulatory tools and approaches to optimize the development process
• Support clients in structuring their regulatory policy capabilities to effectively advance priorities
• Design and implement strategies that engage stakeholders, leverage alliances, and advance regulatory policy

AREAS OF EXPERTISE
Greenleaf’s team of experts provides guidance to medical device and combination product manufacturers, pharmaceutical and biotechnology companies, trade associations, and other stakeholders implementing and complying with the FDA’s digital health requirements. Because there is no one-size-fits-all approach, each solution is built to fit the targeted needs of the client. Greenleaf regularly provides expertise to the following types of clients:

• Start-up and mid-size software companies developing digital health mobile apps
• Drug companies entering the digital health space to enhance the patient or health care provider experience of their products
• Diagnostic testing companies developing applications to read diagnostic test results
• Consumer product companies entering the digital health space with limited FDA regulatory experience
• Investors identifying and evaluating regulatory risks in potential digital health investments
• Trade associations and global drug and medical device companies developing digital health policy strategies
• Artificial intelligence (AI) program developers seeking FDA regulatory insight and clarity
• Telehealth companies partnering with clinical practitioners and life science companies to offer online access to medical products
• Health policy and research organizations developing, tracking, and responding to digital health policies, legislation, and initiatives
• Drug and device companies using digital tools to conduct decentralized clinical trials

ABOUT GREENLEAF HEALTH
Greenleaf Health provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies researching, developing, and manufacturing innovative solutions to pressing global public health challenges. Greenleaf’s robust blend of technical skill and FDA institutional knowledge enables the firm to provide reliable, objective guidance to companies developing medical products for the U.S. market. For more information on Greenleaf Health, visit greenleafhealth.com.

Greenleaf Health, Inc. announces that Mark Kramer, former Director of the FDA’s Office of Combination Products (OCP), has joined the firm as Executive Vice President, Medical Devices and Combination Products.

Mark’s prior experience provides a unique perspective for Greenleaf clients seeking strategic guidance on the development and regulatory review of combination products as well as medical devices, drugs, and biological products. In addition to serving as Director of OCP from 2002 to 2007, Mark was also responsible for establishing the office. In this role, Mark oversaw the development of significant regulations, policies, and practices currently in effect for combination products, including the primary mode of action rule, the cGMP rule, the adverse event reporting rule, numerous guidance documents clarifying the regulation of combination products, and the intercenter consultation process. Mark also has a firsthand understanding, through his management of the FDA’s Product Jurisdiction Program, of how the Agency assigns combination products to Centers for review and determines the regulatory identity of drugs, devices, and biological products for which jurisdiction is unclear or in dispute.

Mark’s work is informed by his training as a biomedical engineer and a 35-year career in medical product regulation that has united technical, front-line regulatory skills with strategic advising and leadership. During his 17 years at the FDA, Mark gained extensive hands-on experience in device evaluation as a lead reviewer and supervisor for a broad range of products: cardiovascular, anesthesiology/respiratory, urology, gastroenterology, surgical, and dental.

Prior to joining Greenleaf, Mark headed an independent consulting practice for over 13 years (2009-2022), advising approximately 200 clients from across the globe, including sponsors of medical devices, combination products, drugs, and biological products, as well as breakthrough and orphan products. In addition to helping clients develop and refine their regulatory strategies, Mark supported sponsors’ regulatory submissions and FDA interactions at all stages of the regulatory process: authoring, strengthening, and submitting initial submissions; developing and critically reviewing responses to FDA-identified deficiencies; preparing for Agency and advisory panel meetings; and advising on cGMPs and adverse event reporting. Mark also spent three years in industry as Chief Regulatory Strategist for GE Healthcare’s medical device business, with executive responsibility for regulatory strategies, processes, and decisions throughout the U.S., Canada, and Latin America. Learn more about Mark Kramer.

About Greenleaf Health

Greenleaf is guided by experts with a combined total of more than 300 years of FDA experience.  Mark joins a distinguished group of professionals at Greenleaf who previously served as leaders throughout the Agency, including: John Taylor, former FDA Counselor to the Commissioner and Principal Deputy Commissioner; Dr. Daniel Schultz, former Director of the FDA’s Center for Devices and Radiological Health (CDRH); Dr. Karen Midthun, former Director of the FDA’s Center for Biologics Evaluation and Research (CBER); Dr. John Jenkins, former Director of the Office of New Drugs for the FDA’s Center for Drug Evaluation and Research (CDER); Dr. Robert Meyer, former Director of CDER’s Office of Drug Evaluation II; Heather Rosecrans, former Director of CDRH’s 510(k) staff; Kate Cook, senior FDA leader in both CDRH and CBER; David Elder, former Director of the FDA’s Office of Regional Affairs and Office of Enforcement; and Cynthia Schnedar, former Director of CDER’s Office of Compliance.

Greenleaf Health provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies researching, developing, and manufacturing innovative solutions to pressing global public health challenges. Greenleaf’s robust blend of technical skill and FDA institutional knowledge enables the firm to provide reliable, objective guidance to companies developing medical products for the U.S. market.

For more information on Greenleaf Health, visit greenleafhealth.com.

Greenleaf Health announces the addition of three former FDA officials to our team of experts. Julia Barrett, M.D., M.P.H., and Chris Leptak, M.D., Ph.D., will join the Drug and Biological Products Team as Executive Vice President and Senior Vice President, respectively. Grace McNally will join the Product Quality, Manufacturing, and Compliance Team as Senior Vice President. 

Julia Barrett, M.D., M.P.H

Dr. Julia Barrett brings more than 28 years of clinical development and regulatory expertise to her role as Executive Vice President, Drug and Biological Products. Julia began her career as a clinical reviewer in the FDA’s Office of Vaccine Research and Review (OVRR) at the Center for Biologics Evaluation and Research (CBER). Prior to joining Greenleaf, Julia spent more than 17 years as a Senior Clinical Consultant at Biologics Consulting Group, where she focused on clinical product development and U.S. regulatory submissions.

Julia’s product expertise includes cell and gene therapy/regenerative medicine, protein therapeutics, allergy immunotherapy, vaccines, toxins, and microbiome-based products. Julia received her bachelor’s degree in biology from Smith College, an M.D. from Northwestern University, and an M.P.H. from George Washington University (GWU). She trained as a resident in internal medicine at the University of Minnesota and completed a fellowship in general internal medicine at GWU. Learn more about Julia Barrett.

Chris Leptak, M.D., Ph.D.

Dr. Chris Leptak joins Greenleaf following a distinguished 14-year career at the FDA, where much of his work focused on biomarker and diagnostic device utility in clinical trials and drug development. Most recently, Chris served as Associate Director, Regulatory Science in the Office of New Drugs (OND) within the FDA’s Center for Drug Evaluation and Research (CDER). During his FDA tenure, Chris led multiple programs and initiatives aimed at developing CDER’s approach to regulatory science, including as Director of the CDER Biomarker Qualification Program, Director of the OND Regulatory Science Program, and Acting Director of the Office of Drug Evaluation Science.

Chris received his undergraduate degree from Yale University and his M.D./Ph.D. at the University of California, San Francisco. Chris completed his residency in emergency medicine at Harvard’s combined Mass General and Brigham program. Learn more about Chris Leptak.

Grace McNally

Grace McNally brings more than 33 years of FDA service to her role as Senior Vice President, Regulatory Compliance at Greenleaf. Grace’s extensive FDA career is highlighted by multiple leadership positions, including her service as Director of the Division of Regulations, Guidance, and Standards within CDER’s Office of Policy for Pharmaceutical Quality; Branch Chief in the Office of Process and Facilities within CDER’s Office of Pharmaceutical Quality; and Compliance Officer within CDER’s Office of Compliance. Grace began her career at the FDA as a field investigator in the Philadelphia District and later joined the Denver District, where she specialized in pharmaceutical and medical device inspections. Grace received her B.S. in physics from Boston College. Learn more about Grace McNally.

About Greenleaf Health

Greenleaf is guided by experts with a combined total of more than 300 years of FDA experience.  Barrett, Leptak, and McNally join a distinguished group of professionals at Greenleaf who previously served as leaders throughout the Agency, including: John Taylor, former FDA Counselor to the Commissioner and Principal Deputy Commissioner; Dr. Daniel Schultz, former Director of the FDA’s Center for Devices and Radiological Health (CDRH); Dr. Karen Midthun, former Director of the FDA’s Center for Biologics Evaluation and Research (CBER); Dr. John Jenkins, former Director of New Drugs for the FDA’s Center for Drug Evaluation and Research (CDER); Dr. Robert Meyer, former Director of CDER’s Office of Drug Evaluation II; Heather Rosecrans, former Director of CDRH’s 510(k) staff; David Elder, former Director of the FDA’s Office of Regional Affairs and Office of Enforcement; and Cynthia Schnedar, former Director of CDER’s Office of Compliance. 

Greenleaf Health provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies researching, developing, and manufacturing innovative solutions to pressing global public health challenges. Greenleaf’s robust blend of technical skill and FDA institutional knowledge enables the firm to provide reliable, objective guidance to companies developing medical products for the U.S. market.

For more information on Greenleaf Health, visit greenleafhealth.com.

Greenleaf Health is expanding its regulatory policy services to further support the needs of clients. A dedicated Regulatory Policy Services Team will be guided by long-time Greenleaf team member, Kate Cook, who will assume a new leadership role at the firm as Principal, Regulatory Policy.

“Since joining Greenleaf more than five years ago, Kate has been a source of both immense regulatory knowledge and exceptional strategic skill. Her inherent leadership abilities, which were well known at the FDA, will guide her team as they build on the valuable regulatory policy services our clients seek,” said John Taylor, President, Greenleaf Health, Inc.

Regulatory Policy Services

Greenleaf’s regulatory policy services are designed to support the needs of large and small clients as they navigate FDA regulations and regulatory policies. The firm’s team of experts works cross-functionally to provide a full-service engagement that assists pharmaceutical and biotechnology companies, medical device manufacturers, patient groups, trade associations, and other stakeholders in communicating effectively about FDA regulatory policy issues and in understanding, implementing, and complying with the FDA’s regulatory programs.

With decades of experience in senior positions at the FDA and throughout industry, Greenleaf’s Regulatory Policy Services Team offers unmatched insight on pre- and postmarket regulatory policy issues, product designations, expedited programs, regulatory intelligence, and scientific policy.

Greenleaf experts draw on their extensive institutional knowledge of the FDA’s overarching regulatory approach, as well as deep and granular expertise regarding FDA regulation of medical product types across the product lifecycle, to provide the following services:

• Assistance with designing and implementing regulatory policy strategies to effectively advance priorities
• Guidance on policy issues related to development programs, combination products, submissions for marketing authorization, and the postapproval phase
• Stakeholder engagement and alliance development to achieve regulatory policy goals
• User fee negotiation support, impact assessment, and program development
• Strategic regulatory guidance for sponsors seeking access to FDA programs and designations, including orphan drug, breakthrough therapy, RMAT, and other expedited pathways
• Regulatory landscape analysis and advice on incorporating novel tools and approaches into development programs

About Kate Cook

Kate joined Greenleaf in 2016 following a distinguished career of more than 20 years at the FDA. In her new role as Principal of Regulatory Policy, Kate will build on the experience she gained over the last five years as Executive Vice President of Drug and Biological Products, coupled with her extensive FDA institutional knowledge, to grow the firm’s services focused on FDA regulatory policies and programs.

Kate’s FDA career began in the Office of Chief Counsel, where she served for more than 15 years as a legal counsel on FDA issues related to such medical products as biosimilars, vaccines, allergenics, human tissue and cellular products, blood products, medical devices, and combination products. She also provided legal guidance on issues related to human subject protection and advertising and promotion.

Kate’s FDA experience included roles as Associate Director for Regulations and Policy within the Center for Devices and Radiological Health (CDRH) and Senior Advisor in the FDA’s Center for Biologics Evaluation and Research (CBER). During her FDA tenure, Kate had a pivotal role in the development and implementation of significant policies, regulations, and strategic initiatives related to drugs, biological products, and medical devices. Learn more about Kate Cook.

ABOUT GREENLEAF

Greenleaf Health provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies researching, developing, and manufacturing innovative solutions to pressing global public health challenges. The firm includes former leaders and regulatory professionals from the FDA, Capitol Hill, top global pharmaceutical and medical device companies, leading law firms, and the top U.S. biotechnology trade organization. Greenleaf’s blend of former FDA officials and industry experts provides a unique set of capabilities when advising entities regulated by the FDA.

Greenleaf is a regulatory consulting firm and does not provide legal advice or legal services.