Greenleaf is expanding the firm’s litigation support services to include a network of experienced and knowledgeable FDA experts adept at advising litigators representing FDA-regulated clients. Greenleaf’s litigation support services utilize the firm’s deep bench and network of experienced and knowledgeable FDA experts to advise litigators grappling with FDA regulatory issues and provide authoritative, objective expert opinions that may make a difference in how disputes are resolved.

Comprehensive Services
Greenleaf professionals and the firm’s network of experts work closely with litigators representing FDA-regulated clients in a wide array of disputes related to medical devices, drug and biological products, and product quality, manufacturing, and compliance. The firm offers litigators access to advisors with the knowledge, qualifications, and experience required to explain and clarify complex FDA regulatory issues to clients, the courts, or juries and serve as credible, persuasive expert witnesses.

Services provided by the Litigation Support Services Network include: advising litigators on the nuances of FDA regulation; preparing expert declarations or reports; and testifying during depositions and at trial. Greenleaf’s team has worked with litigators engaged in a variety of disputes, including complex commercial litigation, unfair competition and false advertising cases, intellectual property litigation, product liability class actions, and securities class actions.

Areas of Expertise
Greenleaf professionals and the firm’s network of experts have extensive, in-depth experience regarding medical device product development, drug and biological product development, the premarket review process, as well as manufacturing, product quality and safety, compliance, and enforcement of all FDA-regulated products.

The Greenleaf Litigation Support Services Network can offer litigators a high-level institutional knowledge of the FDA as well as more granular expertise regarding FDA regulation of a variety of product types across the product lifecycle. Greenleaf’s well-regarded professionals have spent decades working at the FDA in senior positions, allowing them to render thoughtful advice and authoritative opinions.

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.

Greenleaf Health expands its compliance and manufacturing portfolio to include remote quality and compliance support for clients.

Entities regulated by the FDA encounter challenges on a regular basis. But no recent challenge has placed as great of a strain on the life sciences industry as COVID-19. The impact of this global pandemic is experienced by companies of every size, and increased effort and adaptability are required from all parties to preserve the integrity of the supply chain and ensure a consistent supply of safe, high-quality products.

“Greenleaf Health recognizes that quality and compliance activities cannot be stalled. Despite global disruptions in surveillance inspections and other regulatory operations, Greenleaf’s work on behalf of our clients continues. The firm’s team of experts has identified opportunities to assist clients remotely while continuing to support all public health measures in effect throughout the course of the pandemic,” said John Taylor, President, Greenleaf Health, and Principal, Compliance and Regulatory Affairs.

Greenleaf’s remote compliance services concentrate on the FDA’s evolving alternative approaches to on-site inspections that may exist for many months to come. Although not a full substitution for on-site work, the remote opportunities provided by Greenleaf enable companies to continue essential quality and compliance activities while preparing for the time when on-site activities fully or partially resume.

STRATEGIC & TECHNICAL GUIDANCE
Greenleaf’s Product Quality, Manufacturing, and Compliance Team identifies and promotes practices and procedures that will align a client’s approach with the FDA’s quality, safety, and compliance expectations. Greenleaf also engages a network of independent contractors to provide technical expertise, both on site and remotely.

While companies face the complexities of navigating today’s challenging public health landscape, Greenleaf and our network of independent compliance experts are prepared to assist clients with the following remote quality and compliance services:

• Procedural and Record Review. Comprehensive review of new or revised Standard Operating Procedures (SOPs) for acceptability and compliance with requirements and objective evaluation of selected records (e.g., deviations, nonconformance reports, OOS, complaints) for accuracy, completeness, and compliance with requirements.
• Data and Trending Review. Examination of documents and objective feedback on key quality data and metrics, and trending reports prepared for quality or management reviews.
• Corrective Action Assessment. Evaluation of responses, corrective action records, and change control records related to issues identified by the client, or identified during previous inspections by the FDA and other health authorities, and determination of whether the actions are appropriate, complete, and effective.
• Regulatory Response Support. Objective review and expert guidance on providing effective responses to FDA 483s, warning letters, requests for additional information, and other critical regulatory correspondence.
• Issue-Specific Information. Review of information relating to a specific issue of interest identified by the client to provide an objective assessment and feedback to help with resolution, documentation, and communication.
• Training. Live video training on specific topics such as inspection preparedness, design controls, CAPA, etc.

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.

For more information on remote compliance services and Greenleaf Health, visit greenleafhealth.com.

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WASHINGTON, D.C.  – Greenleaf Health, a leading Food and Drug Administration (FDA) regulatory consulting firm, today announces that the firm has expanded its compliance and manufacturing portfolio to include Good Clinical Practice (GCP) services.

Greenleaf’s in-depth knowledge and understanding of the FDA enables the firm to provide unmatched guidance to companies developing products for the U.S. market. Greenleaf experts work with companies to build GCPs that will align a client’s approach with the FDA’s quality, safety, and compliance expectations.

STRATEGIC & TECHNICAL CAPABILITIES

Greenleaf’s expanded GCP services build-on the firm’s already robust compliance portfolio by working with life science entities to evaluate and strengthen clinical quality systems. Greenleaf’s team of regulatory experts use a risk-based methodology to provide strategic and technical guidance to companies designing and executing clinical trials. Because there is no one-size-fits-all approach to GCP compliance, each solution is built to fit the targeted needs of the client, with an eye toward mitigating risks, optimizing processes, and creating a culture of compliance.

Members of Greenleaf’s Product Quality, Manufacturing, and Compliance Team offer a rare blend of perspective developed as leaders in both the public and private sectors. The firm’s wealth of experience enables experts to deliver valuable regulatory and real-world insight. Greenleaf’s tailored GCP services include: complete quality and compliance system assessments; inspection readiness, including mock inspections; comprehensive auditing services; compliance remediation; quality system and inspection readiness training; FDA communications, including analysis of and responses to enforcement letters and facility and supply chain audit reports; and the complete spectrum of compliance and regulatory consultation and guidance.

EXPERT TEAMS

Greenleaf’s team is comprised of experts with a combined total of more than 250 years of FDA experience. With decades of experience in senior positions at the FDA and throughout industry, Greenleaf’s team of respected professionals understand firsthand the importance of accurate and reliable clinical data.

The collective knowledge and extensive experience of the Greenleaf team is enhanced by Greenleaf’s network of specialized technical experts who can be deployed to provide on-site services at entities that manufacture FDA-regulated products.

FULL-SERVICE SUPPORT

Greenleaf professionals work as teams specializing in product quality, manufacturing, and compliance; medical devices and combination products; and drug and biological products. The firm’s comprehensive approach provides a full-service engagement that ensures clients can count on expert direction as they encounter complex regulatory challenges.

Additional services provided by Greenleaf experts include:

• Real World Evidence (RWE): Greenleaf has partnered with Trio Health to provide a cutting-edge combination of technology and regulatory insight via Trio Health’s innovative RWE technology platform.
• Cell & Gene Therapy: Greenleaf assists sponsors of cell and gene therapies by optimizing FDA interactions and submissions to support development, manufacturing, quality, and regulatory review.
• Advisory Services: Greenleaf understands the complex environment within which life sciences transactions take place and frequently advises investors to evaluate potential issues and regulatory risks that may be identified during such transactions.

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.

For more information on GCP services and Greenleaf Health, visit greenleafhealth.com.

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Firm Announces Dr. Midthun as Principal, Drug and Biological Products

WASHINGTON, D.C. – Greenleaf Health, Inc. (Greenleaf), a leading Food and Drug Administration (FDA or agency) regulatory consulting firm, today announces that Karen Midthun, M.D., has joined the firm as Principal, Drug and Biological Products.

Dr. Midthun joins fellow principals Drs. John Jenkins and Bob Meyer to co-lead the firm’s Drug and Biological Products Team. In this role, Dr. Midthun will contribute specialized insight — informed by her regulatory, research, and clinical experience — to the strategic and technical guidance that Greenleaf provides to FDA-regulated entities developing improved products to prevent the spread of infectious diseases, addressing ongoing public health needs for biologics, and advancing growing fields such as regenerative medicine.

About Dr. Midthun

Dr. Midthun joins Greenleaf following a distinguished 28-year career in public service, of which 22 years were dedicated to the FDA. An infectious disease physician by training, Dr. Midthun most recently served as the Director of the FDA’s Center for Biologics Evaluation and Research (CBER). Prior to her role as Center Director, Dr. Midthun served as the Deputy Director of CBER and the Director of the Office of Vaccines Research and Review within CBER. 

During her FDA tenure, Dr. Midthun played a critical role in facilitating policy and technology development in the areas of blood products, vaccines, and cell, tissue, and gene therapies. Under her leadership, the FDA approved several vaccines that have had a significant public health impact, including vaccines for pneumococcal disease, meningococcal disease, and human papilloma virus. Dr. Midthun received praise for her work responding to the 2009 influenza pandemic; developing a framework for the regulation of human cell and tissue products; and, in collaboration with the Center for Drug Evaluation and Research (CDER), developing a policy for the regulation of biosimilar products.

Before joining the FDA in 1993, Dr. Midthun was on the faculty of the Department of International Health at the Johns Hopkins Bloomberg School of Public Health, where she was involved in the clinical development of investigational vaccines and was an attending physician at the Johns Hopkins Hospital. 

Dr. Midthun received her bachelor’s degree from the Massachusetts Institute of Technology (MIT) and her medical degree from the George Washington University School of Medicine. She trained as a resident in internal medicine at Johns Hopkins Hospital and as a fellow in infectious diseases at Johns Hopkins Hospital and the National Institute of Allergy and Infectious Diseases (NIAID). She is a fellow of the Infectious Diseases Society of America and a member of the American College of Physicians.

About Greenleaf’s Drug and Biological Products Team

Greenleaf’s Drug and Biological Products Team delivers a variety of services, including: monitoring and assessing the regulatory environment for emerging trends; analyzing the impact of agency actions on current development programs; and reviewing the competitive landscape for specific therapeutic areas.

Greenleaf experts specialize in clinical trial design, FDA submissions and the review process, and postmarket requirements, including safety monitoring. The team’s approach, firmly grounded in established principles of public health practices, is guided by decades of regulatory experience in drug and biological product development, spanning all therapeutic areas.

About Greenleaf Health

Greenleaf Health provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies developing and manufacturing innovative solutions to pressing global public health challenges. Greenleaf’s team of experts has more than 225 years of combined FDA experience, and as such, provides a wealth of regulatory knowledge that is unmatched.

Dr. Midthun joins several former FDA officials at Greenleaf, including Patrick Ronan, former FDA Chief of Staff; John Taylor, former FDA Counselor to the Commissioner and Principal Deputy Commissioner; Dr. John Jenkins, former Director of the Office of New Drugs for FDA’s Center for Drug Evaluation and Research (CDER); Dr. Daniel Schultz, former Director of FDA’s Center for Devices and Radiological Health (CDRH); Dr. Bob Meyer, former Director of the Office of Drug Evaluation II within CDER; and Michael Chappell, former Associate Commissioner for Regulatory Affairs. Greenleaf’s blend of former FDA officials and industry experts provides a unique set of capabilities when advising entities regulated by the FDA.

For more information on Dr. Midthun and Greenleaf Health, visit greenleafhealth.com.

Greenleaf Health announces that Kristen Grumet has joined the firm as Senior Vice President, Regulatory Compliance.  The addition of Grumet to Greenleaf’s team of experts further enhances the firm’s expanded portfolio of comprehensive compliance services, which now include inspection readiness, on-site compliance assessments, and remediation.

About Grumet

Kristen Grumet is an expert in the field of medical device compliance.  In addition to almost a decade of experience as an FDA field investigator, Grumet’s professional background includes 16-years of quality systems compliance management and consulting within the medical device industry.

A Phase II-certified medical device performance auditor, Kristen has the distinction of being among the first cadre of certified medical device investigators in FDA history. During her service at the FDA, Grumet inspected both domestic and International medical device manufacturers to ensure compliance with Quality System Regulations (QSRs).  Grumet was responsible for documenting and developing numerous regulatory cases, including warning letters, seizures and corporate-wide injunctions.

Grumet’s 20+ years of industry experience includes positions at NSF Health Sciences; Intuitive Surgical, Inc.; Quintiles Consulting; and LifeScan, Inc.  Her work with medical device companies provided experience leading projects across the spectrum of quality assurance and regulatory compliance activities, including compliance assessments; internal audits and investigations; quality systems development and implementation; corrective action planning and quality system remediation; and QSR and FDA inspection readiness training.  Grumet’s impressive portfolio also includes numerous FDA and industry presentations and publications.

At Greenleaf, Grumet joins the firm’s Product Quality, Manufacturing & Compliance team, where she will serve as Senior Vice President, Regulatory Compliance.  In this role, Grumet will continue to provide medical technology clients with customized guidance and support in developing and implementing strong corporate quality systems and regulatory strategies for compliance.

Greenleaf’s Expanded Compliance Services

Greenleaf’s Product Quality, Manufacturing, and Compliance Team has a proven track record of providing excellent services to life science companies seeking strategic and technical expertise to strengthen their quality management systems and guide them through challenging quality and compliance matters.  In addition to Greenleaf’s core regulatory consulting services, the firm recently expanded its compliance service portfolio to include expanded remediation, auditing, and compliance services.  Greenleaf’s compliance capabilities now include:

• Inspection Readiness:  Greenleaf experts strengthen clients’ readiness for FDA pre-approval and surveillance inspections through training, mentoring, audits and mock inspections.
• Compliance Assessments: Greenleaf works with life science firms to evaluate and strengthen compliance functions with an eye towards optimizing processes, mitigating risks, and creating a culture of compliance.  The Greenleaf team performs objective audits and assessments of a clients’ operations to identify strengths and areas of needed improvement, while continuing to meet business objectives.
• Compliance Remediation:  Greenleaf’s experts bring an unmatched level of experience and insight when guiding companies along the remediation pathway.Greenleaf’s services address the complete scope of remediation, from acute enforcement actions, to strategic development and implementation of remediation plans.

By expanding Greenleaf’s compliance service portfolio, the firm is now capable of providing a full-service experience for companies navigating today’s evolving FDA regulatory environment.

About Greenleaf Health

Greenleaf Health provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies developing and manufacturing innovative solutions to pressing global public health challenges.

Greenleaf’s team of experts draws on a combined total of more than 200 years of FDA experience. Members of the firm’s Product Quality, Manufacturing, and Compliance Team include former leaders and regulatory experts from the FDA, Capitol Hill, top global pharmaceutical companies, leading law firms and the top U.S. biotechnology trade organization. Greenleaf’s robust blend of regulatory expertise and FDA institutional knowledge allows the firm to provide unmatched regulatory guidance.

For more information on Kristen Grumet visit her bio.