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.

Kristen C. Grumet

Senior Vice President, Regulatory Compliance

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 23 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 the use of the questionnaire. She was a Phase II-certified performance auditor in the area of medical devices at 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 and validation program development and implementation; corrective action planning and quality system remediation; 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.

Kristen has presented at FDA design control workshops and for a wide range of compliance-related seminars for the medical device industry and will continue to communicate expert advice through presentations and publications.

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, J.D., M.P.H.

Executive Vice President, Regulatory Compliance and Deputy General Counsel

Kalah has 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 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.

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