Thomas R. Berry, Pharm.D.

Senior Vice President, Regulatory Compliance

Tom Berry brings more than 20 years of extensive regulatory experience to his role as Senior Vice President, Regulatory Compliance at Greenleaf Health.

Tom is a retired Captain with 23 years in the U.S. Public Health Service (USPHS) and six years as an Army Pharmacy Officer. He was assigned to multiple positions over his 20 years with the FDA, most recently as a Pharmaceutical Program Expert in the Office of Regulatory Affairs (ORA), responsible for providing guidance to ORA field components, drafting FDA policy, reviewing proposed guidance and legislation, and representing ORA on FDA committees. He also trained “new hire” investigators and was a cadre member for courses in Food and Drug Law, Evidence and Development, and New Hire Fundamentals. Tom was an original author of “FMD-153 Investigations of Facilities engaged in the Manufacturing, Packaging, Labeling, and Testing of Medical Products that may be subject to an Emergency Use Authorization (EUA).” As the past Director of Compliance, Denver District and member of the FDA Cannabis Product Council, he is familiar with FDA cannabis oversight operations and cannabis regulatory history to include “Brownie Mary,” Charlotte Figi, Colorado Amendment 64, and the 2018 Farm Bill.

Tom began his FDA career as an investigator for eight years in the Raleigh, NC resident post, where he was a domestic and international drug, bioresearch monitoring (BIMO), and pharmacovigilance investigator. He was selected as a Compliance Officer in Denver and subsequently as the Director of the Compliance Branch, with responsibility for assessment of inspection reports, initiation of compliance actions, and evaluation of compliance action effectiveness.

After ORA Program Alignment in May 2017, Tom conducted a 180-day detail to establish the BIMO Program West Division responsible for the oversight of BIMO operations in the Western 27 States. He subsequently assumed his permanent position as Director of Compliance, Office of Pharmaceutical Quality Operations IV, with oversight of the pharmaceutical operations in the Western 13 States and global inspection regulatory assessments. At Greenleaf, Tom provides strategic guidance and support to pharmaceutical, pharmacovigilance, and cannabis companies, including: developing compliance strategies; performing due diligence activities; ensuring inspection readiness; assisting industry clients and legal counsel in developing and communicating corrective action plans that meet FDA expectations and that achieve and sustain compliance; conducting audits and mock inspections; and providing training, coaching, and mentoring. Tom continues to communicate expert advice through presentations at FDA and industry conferences and articles published in industry journals.

Tom received a B.S. in pharmacy and a Pharm.D. from Creighton University and completed an ASHP-certified residency at Fitzsimons Army Medical Center. 

Dawn Wydner

Senior Vice President, Regulatory Compliance

Dawn Wydner joined Greenleaf Health as Senior Vice President, Regulatory Compliance, after working closely with Greenleaf’s Quality, Manufacturing, and Compliance Team as an independent consultant. Dawn has extensive FDA regulatory compliance expertise as well as quality and compliance experience within industry. During her ten years at the U.S. Food and Drug Administration (FDA), she was a Commissioned Public Health Service Medical Officer, conducting complex, thorough bioresearch monitoring (BIMO) inspections to assess good clinical practices (GCPs), good laboratory practices (GLPs), and good manufacturing practices (GMPs) under medical device and drug compliance programs domestically and internationally. She has also worked in bioresearch quality and compliance and clinical quality assurance roles for Janssen Research & Development, where she managed company-wide, global compliance activities and provided expert strategic direction and advice to senior leadership.

Dawn offers Greenleaf clients a deep understanding of all aspects of operational strategy, coordination, and conduct to ensure quality, safety, and compliance across the global pharmaceutical R&D, medical device, and consumer products industries. Her expertise covers the end-to-end lifecycle of a product and processes from GLP to GCP to GMP, including postmarketing surveillance; audits and compliance, safety, and quality monitoring; and operational risk management across all GxPs. She is frequently sought as a subject matter expert based on her proven track record of consistently establishing proactive compliance and application of quality oversight. Dawn is adept at utilizing her broad skillset to enable easy collaboration, big-picture strategic thinking, and compliance mindsets.

Prior to her career at the FDA, Dawn worked as a Registered Nurse in the hospital setting, caring for patients within transitional trauma, pediatrics, infectious diseases, and oncology. She has obtained her Ph.D. in Health Psychology and RQAP-GCP certification. 

Maria Bonner

Vice President, Regulatory Compliance and Deputy General Counsel

Maria is a Vice President in Greenleaf’s regulatory compliance group, where she provides strategic and regulatory advice to clients. Maria also serves as Greenleaf’s in-house Deputy General Counsel. 

Prior to joining Greenleaf, Maria gained policy and legal experience in both the private and public sectors. She formerly served at the White House in several roles. She served on the Domestic Policy Council as Deputy Director and Special Assistant to the President. Maria also served as the Deputy Associate Counsel in the Office of the Vice President. 

Maria’s previous private sector experience included consulting and legal roles. Maria was at Greenleaf in the regulatory compliance group. 

She formerly was at a global law firm in the litigation and international arbitration group. Before pursuing her law degree, Maria was an Analyst at an international business and economic public policy consultancy. She worked principally with the Managing Directors, former administration alumni including a President’s Chief of Staff, in providing key policy advice to clients.

Maria earned her J.D. from Georgetown University Law Center and her B.A. from Georgetown University, graduating summa cum laude and Phi Beta Kappa. 

Evaluation & Development of a Cell and Gene Therapy Quality Management System

A biopharmaceutical company well-versed in small molecule manufacturing processes requested Greenleaf’s support in building out its cell and gene therapy (CGT) manufacturing facility processes. Specifically, Greenleaf was asked to assist in developing the company’s Quality Management System (QMS) for new modalities in order to understand its positioning for sustainability and expansion of operations.  Greenleaf experts …

Retrospective Assessment of Systemic Compliance Concerns

In response to an FDA warning letter request, a multinational pharmaceutical company selected Greenleaf Health as an independent third-party expert to perform retrospective assessment of out-of-specification (OOS) investigations and a systemic assessment of systems for investigations. Greenleaf experts developed a protocol for performing the retrospective review, which established the conclusiveness of OOS investigative results, determined …

Evaluating Systemic Manufacturing Compliance and Identifying Actionable Quality Recommendations

Following a string of what appeared to be isolated enforcement actions, a multinational pharmaceutical and medical device company requested Greenleaf’s assistance in evaluating the company’s manufacturing network for systemic compliance concerns. Greenleaf experts performed audits at 20 different locations in the United States and in six European countries. Two-person baseline audit teams, consisting of experts …

Medical Device Auditing and Certification for Compliance with FDA Guidelines

Greenleaf was selected by a multinational medical device company to serve as an independent GMP and Medical Device Reporting (MDR) expert. In this role, Greenleaf was made responsible for performing initial audits and procedural reviews at the company’s locations in the U.S. and Asia. Greenleaf’s work started with a review of company policies and procedures; …

Conducting Due Diligence to Guide a Corporate Acquisition Decision

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 …

Madeleine Giaquinto, J.D.

Director, Regulatory Affairs

Madeleine Giaquinto offers a robust portfolio of regulatory compliance and federal healthcare advocacy experience, spanning legal, nonprofit, government affairs, and public health policy settings.

In her role as Director of Regulatory Affairs at Greenleaf Health, Madeleine provides clients with timely analysis of FDA regulations, policies, and guidance documents related to good practice standards for drugs, biologics, medical devices, dietary supplements, and CBD.  In addition, she advises clients on strategic engagement with FDA regarding a range of compliance issues, such as remediating deficiencies identified in FDA Form 483 observations and FDA Warning Letters, as well as building cultures of quality within mature quality management systems.

She has published articles on topics ranging from the root causes of drug shortages along global supply chains, DOJ’s evaluation of corporate compliance programs in the context of FDA-regulated products, and FDA’s regulatory activities in response to COVID-19 and in future pandemic preparedness efforts.

Before joining Greenleaf Health, Madeleine gained legal and government relations experience at 340B Health, a membership organization of hospitals and health systems within the federal 340B drug pricing program. Her role involved researching and analyzing implications of 340B development and educating members on issues involving program compliance, implementation, and advocacy strategies. Madeleine also worked at Mintz Levin Strategies, where she tracked and analyzed development of various federal and state healthcare policies.

Before earning her law degree, Madeleine worked at MedStar Georgetown University Hospital managing the Department of Pediatrics’ compliance with healthcare provider credentialing requirements of various regulatory authorities.

Madeleine received a B.S. in Biology from Georgetown University and a J.D. from George Mason University School of Law.

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