Learn how Greenleaf works with clients to devise effective solutions to their most complex regulatory challenges.
Greenleaf Health was engaged by a global medical device company to assist in conducting due diligence for the potential acquisition of another device company. Greenleaf’s Advisory Services Team evaluated the target company’s FDA compliance history and regulatory status, as well as their promotional and advertising materials, in order to assess the regulatory risk that would …
Greenleaf Health assisted a mid-sized pharmaceutical company in developing a regulatory strategy to address safety and trial conduct issues in the phase 3 program for their lead compound for cardiovascular disease. During phase 3 trials, the client identified a consequential safety event and sought Greenleaf’s guidance on both addressing the safety event in the context …
Madeleine Giaquinto offers a robust portfolio of public health policy and regulatory compliance expertise that spans a career of nearly 10 years working across legal, government/legislative affairs, and hospital administrative environments.
At Greenleaf Health, Madeleine helps clients navigate complex landscapes of FDA regulation, policy, guidance, and GXP standards for drugs, biologics, medical devices, dietary supplements, cannabidiol (CBD) and cannabis-derived products, cosmetics, and tobacco-related products. She advises clients through strategic engagement with the FDA on wide-ranging compliance issues, such as remediating deficiencies identified in FDA Form 483s and warning letters and building mature quality management systems.
Madeleine has spoken on panels and published articles analyzing the regulatory impacts of a host of timely topics, including root causes of drug shortages, FDA warning letter trends, implementation of the Drug Supply Chain Security Act (DSCSA), advanced and continuous drug manufacturing technologies, and the development of a regulatory framework for CBD and cannabis-derived products. She serves on the Food and Drug Law Institute’s (FDLI) Austern Writing Awards Committee, focused on fostering the next generation of professionals in the food and drug law field.
Prior to joining Greenleaf Health, Madeleine worked on legal and government relations teams at 340B Health, a membership organization of hospitals and health care systems that participate in the federal 340B drug pricing program. Her role involved researching and analyzing implications of 340B program development, and educating members on program compliance, implementation, and advocacy strategies. Madeleine also previously worked at Mintz Levin Strategies, LLC, where she tracked and analyzed development of various federal and state health care bills and policies. She has also spent time in health care practices managing compliance with practitioner credentialing requirements of federal, state, and local regulatory authorities.
Madeleine has a B.S. in biology from Georgetown University and a J.D. from George Mason University School of Law.
Kristen is an expert in the field of medical device compliance, with 9 years of experience as an FDA Field Investigator specializing in medical devices and more than 25 years of quality systems compliance management and consulting for the industry. As a member of FDA’s Design Control Inspection Strategy (DCIS) Team and FDA’s Pacific Region Design Control Training Cadre, Kristen contributed to the development and implementation of the DCIS questionnaire for medical device inspections and trained companies in use of the questionnaire. She was a Phase II-certified performance auditor in the area of medical devices at the FDA and has the distinction of being part of the first cadre of certified medical device investigators in FDA history, conducting numerous inspections of European medical device facilities during her six-year tenure with the FDA foreign inspection cadre.
In her work with medical device companies, Kristen has managed successful Third-Party Certifications for companies under Consent Decree. She has led projects across the spectrum of quality assurance and regulatory compliance activities, including: compliance assessments; internal audits and investigations; quality systems program development and implementation; corrective action planning and quality system remediation; combination product training; and QSR and FDA inspection readiness training.
As Senior Vice President of Regulatory Compliance at Greenleaf Health, Kristen continues to provide medical technology clients with customized guidance and support in developing and implementing strong corporate quality systems and regulatory strategies for compliance, as well as focused reviews of quality issues such as management of medical device recalls.
Kristen has presented at FDA design control workshops and a wide range of compliance-related seminars for the medical device industry and provides expert advice through webinars, presentations, and publications in industry forums such as the Food and Drug Law Institute (FDLI) and FDANews.
Kristen has a degree in environmental population and organismal biology from the University of Colorado, Boulder. She also has extensive FDA-sponsored training in areas such as performance and quality audits, design control and process validation requirements, and medical device quality management system requirements.
Kalah Auchincloss has more than 15 years of food and drug legal, policy, and regulatory experience at the FDA, on Capitol Hill, and in the private sector. Kalah spent six years at the FDA, including as Deputy Chief of Staff for two FDA Commissioners, Dr. Robert Califf and Dr. Scott Gottlieb. As Deputy Chief of Staff, Kalah worked with senior FDA leadership to manage crises, develop policy decisions, implement communications strategies, and liaise with the Department of Health and Human Services, the White House, and other agencies. Kalah was also a primary point of contact in the immediate Office of the Commissioner for the six FDA Centers and other components of the Commissioner’s Office.
Prior to that role, Kalah spent time on Capitol Hill as the FDA detailee to the Senate Committee on Health, Education, Labor, and Pensions, working on the 21st Century Cures Act and other FDA-related legislation. She has also served in the FDA’s Center for Drug Evaluation and Research (CDER) as a regulatory counsel in the Office of Regulatory Policy, and as Director of CDER’s Office of Unapproved Drugs and Labeling Compliance in the Office of Compliance, leading a team of more than 50 staff working on pharmacy compounding, unapproved drugs, over-the-counter drugs, and other enforcement issues.
Before joining the FDA, Kalah was an associate at the law firm Foley Hoag LLP, in the firm’s health care practice group.
As an Executive Vice President at Greenleaf, Kalah is continuing her commitment to public health by providing strategic counsel to clients on compliance, enforcement, and policy matters. Kalah counsels clients across a range of product sectors and is knowledgeable about multiple areas of FDA regulation, including drugs, compounding, unapproved drugs, diagnostics, digital health, cosmetics, and cell and gene therapy.
Kalah holds a B.A. with honors from Williams College, a J.D. with honors from Georgetown University Law Center, and an M.P.H. from Harvard University.
Laura Bartee serves as Greenleaf Health’s Executive Director of Operations, Regulatory Compliance, bringing with her more than ten years of experience as an administrative professional and demonstrated success in managing office operations, corporate events, and customer experiences.
Prior to joining Greenleaf, Laura served as Legal Personnel Coordinator in the Washington, DC office of Cleary Gottlieb Steen and Hamilton LLP (“Cleary”). Laura spearheaded the onboarding and training of new associates and worked with the recruiting team to plan the Summer Associate Program. She also played a significant role in executing the firm’s professional and social events.
Prior to her work at Cleary, Laura served as Utilization Coordinator for the Northeastern Region of Tennessee for Enterprise Rent-A-Car, facilitating the distribution of new cars throughout the region, as well as the removal of used cars from the fleet. Laura also managed the region’s team of drivers, efficiently allocating them to add and remove cars from the region’s rental offices. Laura began her career at Enterprise Rent-A-Car as an Assistant Branch Manager in various rental branches throughout the region.
Laura received her undergraduate degree, with Honors, from King University (formerly King College) in Bristol, Tennessee.
David Elder brings more than 35 years of extensive regulatory experience to his role as Principal, Regulatory Compliance at Greenleaf Health. A 23-year veteran of the U.S. Food and Drug Administration (FDA) and U.S. Public Health Service (USPHS), David served as a senior FDA official with prominent roles in domestic and foreign inspections, recalls and emergencies, and compliance actions involving hundreds of situations. He has testified in federal court and before Congress, initiated and approved enforcement actions, and represented the FDA during national media events. Additionally, David has received numerous honors, including the Distinguished Service Medal.
David began his FDA career as an Investigator in the Boston District Office where he conducted domestic and foreign inspections and investigations in various program areas. He was selected as a Compliance Officer and later as the Director of the Compliance Branch with responsibility for assessment of inspection reports, initiation of compliance actions, and evaluation of compliance action effectiveness.
David transferred to FDA headquarters when he was selected as the Director of the FDA Office of Enforcement in 2003, a position he held for the next six years. In this Senior Executive Service position, David led the Office with responsibility for agency enforcement policy, agency recall policy and operations, and enforcement strategy and case review. In 2009, David transferred from the Office of Enforcement to the Office of Regional Operations where he led the Office with responsibility for policy and operations related to foreign inspections, domestic inspections, import operations, and field science. In both roles, David served as a principal advisor to the FDA’s Associate Commissioner of Regulatory Affairs.
Prior to joining Greenleaf, David served as Vice President with PAREXEL International. He traveled to client locations across the U.S. and in 14 foreign countries to conduct audits and mock inspections; provide training, coaching, and mentoring; and advise clients on the development and communication of corrective actions that meet FDA expectations and that achieve and sustain compliance.
At Greenleaf, David continues to provide strategic guidance and support to pharmaceutical and medical technology companies in areas including: strengthening corporate quality systems; developing compliance strategies; supporting inspections and ensuring inspection readiness; assisting industry clients and legal counsel in developing and communicating corrective action plans in response to compliance issues; verifying completed corrective actions; executive training and coaching; and performing due diligence. David also communicates expert advice through presentations at FDA and industry conferences, articles published in industry journals, and FDLI’s 2022 book, How FDA Really Works: Insights from the Experts.
David received a B.S. in electrical engineering from Boston University and attended executive management courses at Harvard University.
Liz brings more than ten years of regulatory experience and diverse knowledge of legal and public policy matters to her position as Senior Vice President of Regulatory Compliance.
Liz provides strategic guidance on premarket and postmarket issues, specifically related to regulatory compliance. She works with pharmaceutical and medical device clients to prepare for FDA inspection and to address and remediate compliance matters. She advises clients on FDA communication, including 483 and warning letter responses, and offers guidance on agency expectations and regulatory policy.
Liz has particular expertise in two of the FDA’s newest regulated product categories, tobacco and cannabis-derived products. Liz advises clients navigating the regulatory landscape for tobacco products and assists with content and format of applications, interpretation of FDA regulation, engagement with the FDA, and policy development. Liz is well versed in the regulatory barriers facing the rapidly growing cannabis industry. She offers strategic guidance and risk-based strategies to CBD manufacturers and distributors as the FDA contemplates how to regulate the product category.
Prior to joining Greenleaf Health, Liz served as Director of Educational Programming for the Food and Drug Law Institute (FDLI) in Washington, D.C. While at FDLI, she gained extensive experience in all FDA-regulated product areas. Liz’s role included regularly corresponding with FDA officials, as well as creating and supervising the development of curricula for an array of educational programs. She led FDLI’s committees responsible for monitoring regulatory developments in the tobacco and pharmaceutical industries and served as Editor-in-Chief of the Food and Drug Law Journal.
Before earning her law degree, Liz worked as a government relations professional for the Society of Chemical Manufacturers and Affiliates (SOCMA), where she directed a grassroots network of more than 100 member companies. Liz earned a B.S. in political science from the University of Arizona and a J.D. from the University of the District of Columbia’s David A. Clarke School of Law.
With more than 30 years of experience as an expert in compliance issues – including more than 20 years in leadership positions in the government – Cynthia adds to Greenleaf Health’s prestige as Principal, Regulatory Compliance.
Cynthia was formerly Director of the Office of Compliance for the FDA’s Center for Drug Evaluation and Research (CDER), where she led regulatory enforcement efforts to ensure companies comply with federal standards for quality and safety. Cynthia’s commitment to quality continues in her work advising Greenleaf clients on GCP and GMP issues across the product lifecycle.
In addition to serving at the FDA, Cynthia spent more than two decades at the Department of Justice (DOJ), where she specialized in compliance and enforcement issues. As Deputy Inspector General and Acting Inspector General, she led a nationwide staff in investigating allegations of corruption and misconduct and conducting independent audits of department programs. Through her other roles at DOJ, Cynthia acquired an extensive background in criminal and civil enforcement work, serving as Counselor to the Inspector General, Deputy Chief of the Sex Offense and Domestic Violence Section in the U. S. Attorney’s Office for the District of Columbia, Assistant U.S. Attorney, and Trial Attorney in the Civil Fraud Section of the Civil Division.
Previously, Cynthia clerked for the Honorable James R. Browning on the U.S. Court of Appeals for the Ninth Circuit and worked as a television reporter in New Mexico and Texas.
Cynthia earned a B.A., with distinction, from the University of New Mexico and a J.D., with honors, from the University of Texas School of Law.
Cynthia serves as a board member for both the Food and Drug Law Institute and the FDANews Editorial Advisory Board.
For more than 30 years, John Taylor has made significant contributions to the public health, serving in senior leadership positions within the Food and Drug Administration (FDA), industry, and consulting services. John joined Greenleaf following a distinguished career of more than 20 years at the FDA. During John’s time at the Agency, he led several of its priority initiatives. At Greenleaf, John continues his commitment to health care innovation as the firm’s President and Principal of Compliance and Regulatory Affairs, providing strategic consultation to FDA-regulated clients on enforcement and compliance matters.
From 2009 to 2014, John held three high-profile positions at the FDA: Counselor to the Commissioner, Acting Principal Deputy Commissioner, and Acting Deputy Commissioner for Global Regulatory Operations and Policy.
As Counselor to the Commissioner, John served as the principal advisor to Commissioner Margaret Hamburg on issues that affected the agency’s programs, policymaking, management, budget, and administration. In his role as Acting Deputy Commissioner for Global Regulatory Operations and Policy, John provided leadership and direction to more than 4,000 employees in the FDA’s Office of Regulatory Affairs (ORA) and Office of International Programs.
John began his career at the FDA in 1991 as an attorney within the Office of the Chief Counsel, responsible for all phases of criminal and civil litigation related to violations of the Federal Food, Drug, and Cosmetic Act and other federal laws. In 1997, John was promoted to Senior Advisor for Regulatory Operations and Policy within the FDA’s Office of the Commissioner. He was later named Director of the Center for Drug Evaluation and Research’s Office of Compliance. In 2000, John accepted the position of Director of ORA’s Office of Enforcement. Two years later, John was promoted to Associate Commissioner for Regulatory Affairs.
In 2005, John left the FDA to spend four years working in industry, first as Divisional Vice President for Federal Government Affairs at Abbott, then, in 2007, as Executive Vice President for Health at the Biotechnology Industry Organization.
John has worked closely with many professional associations, serving on the boards of the Food and Drug Alumni Association and the Food and Drug Law Institute. He currently serves on the United States Pharmacopeia Board of Trustees.
John received his J.D. from the College of William and Mary and is a graduate of Pennsylvania State University with a B.A. in History.
