Cosmetics Regulatory Services

Madeleine Giaquinto, J.D.

Director, Regulatory Affairs

Background:
- 9+ years in public health policy and regulatory compliance professional services
Specialty:
- FDA regulation of drugs, biologics, medical devices, dietary supplements, cannabis-derived products, cosmetics, and tobacco-related products
Experience:
- FDA regulatory consulting and strategic engagement | Federal health care legislation and public health policy research & analysis

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.

Kalah Auchincloss, J.D., M.P.H.

Executive Vice President, Regulatory Compliance & Deputy General Counsel

Specialty:
- Regulatory compliance | Regulatory policy | Litigation support
Experience:
- 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 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.

Samantha Eakes

Vice President, Regulatory Affairs

Background:
- Public health, public policy, and non-profit sector
Specialty:
- FDA regulation of medical devices and combination products | Premarket medical device submissions
Experience:
- 7+ years of FDA regulatory consulting experience

Samantha brings more than seven years of FDA regulatory consulting experience and a diverse background in public health, public policy, and the nonprofit sector to her position as Vice President of Regulatory Affairs.

Through her public health studies and prior experience, Samantha acquired critical public health knowledge that allows her to effectively assist clients with developing communications and advocacy strategies, stay informed on evolving regulatory requirements, and provide strategic insight on critical regulatory challenges.

In her role at Greenleaf, Samantha advises clients regarding potential FDA regulatory pathways for their devices and assists clients with their FDA submissions and correspondence. She reviews, drafts, and files FDA premarket submissions for medical device clients, including: Pre-Submissions (Pre-Subs); Submission Issue Requests (SIRs); Requests for Designation (RFDs); Breakthrough Device Designation Requests; Investigational Device Exemptions (IDEs); 510(k) Premarket Notifications; Premarket Approval Applications (PMAs); and Emergency Use Authorizations (EUAs). Samantha also conducts research for medical device clients to use in strategic planning and analyzes the regulatory landscape using FDA databases, regulations, policies, and guidance documents.

Samantha has published articles on medical device-related topics such as cybersecurity and the FDA’s least burdensome provisions.

Prior to joining Greenleaf, Samantha gained policy and advocacy experience at Management Sciences for Health (MSH). She also previously volunteered with Arts for Dementia, an organization in London, England, that provides art and music therapy for individuals living with dementia and Alzheimer’s disease.

Samantha earned a B.A. in psychology from Boston University and an M.P.H. from Boston University’s School of Public Health.

Elizabeth Oestreich

Senior Vice President, Regulatory Compliance

Background:
- 10+ years of FDA regulatory experience
Specialty:
- Strategic guidance on regulatory compliance | The Family Smoking Prevention and Tobacco Control Act and FDA regulation of tobacco products | FDA regulation of cannabidiol (CBD)

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.

Cynthia Schnedar

Principal, Regulatory Compliance

Background:
- Formerly Director of the Office of Compliance for FDA’s Center for Drug Evaluation and Research (CDER)
Experience:
- 30 years as an expert in compliance and enforcement issues, serving in leadership roles at both FDA and DOJ
Awards:
- FDA Commissioner’s Special Citation and the FDA CDER Special Recognition Award in 2015
- Attorney General’s Distinguished Service Award in 2009

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.

John Taylor

President and Principal, Compliance and Regulatory Affairs

Background:
- 20 years at the FDA
Specialty:
- Regulatory policy, compliance, and enforcement
Experience:
- Industry experience with medical device, biotech, and pharmaceutical sectors
Awards:
- Health and Human Services Secretary’s Award for Distinguished Service (1997, 2000, 2003, 2004, 2005, 2011)
- FDA Award of Merit (2000, 2003, 2005)

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.

Maura M. Norden, J.D.

Executive Vice President, Medical Devices and Combination Products & General Counsel

Background:
- More than 15 years advising FDA-regulated entities, investors, and public health organizations on a broad range of FDA regulatory matters
Specialty:
- FDA statutes, regulations, and policy | Development, clearance and approval, and marketing of FDA-regulated products | FDA regulation of in vitro diagnostics and laboratory-developed tests | FDA regulatory due diligence | FDA regulation of digital health
Experience:
- Joined Greenleaf after almost a decade of professional experience in the food, drug, and medical device practice group at a large, multinational law firm

Maura Norden joined Greenleaf from the law firm Sidley Austin LLP in January 2015, following nearly a decade advising leading medical device and drug companies and investors on a broad range of FDA regulatory matters.

Maura uses her comprehensive and in-depth understanding of the FDA’s statutory jurisdiction, regulatory requirements, and regulatory processes to provide strategic advice to FDA-regulated companies throughout the product lifecycle, from development to FDA premarket review and postmarket regulation. Maura advises a broad range of clients, including early-stage companies, large, multinational industry leaders, trade associations, and public health groups.

More specifically, Maura’s experience includes advising:

Digital health companies on the FDA’s evolving approach to digital health products;
Consumer technology companies with respect to potential FDA regulation under the medical device provisions of the Federal Food, Drug, and Cosmetic Act;
Clinical laboratory clients regarding the FDA’s historical and current policies related to laboratory-developed tests (LDTs);
FDA-regulated firms on compliance with FDA promotional requirements, drawing on experience gained during temporary assignments to multinational pharmaceutical companies, where she sat on copy review committees;
Cosmetics companies with respect to permissible claims for cosmetic products;
Investors by providing strategic advice and conducting regulatory assessments in connection with due diligence for transactions and working with investors post acquisition on integration activities;
Trade associations and other public-health-focused organizations developing positions on various FDA policies, reports, proposed rules, and guidance documents;
In vitro diagnostic (IVD) companies on product development, regulatory pathway questions, and premarket review issues; and
A range of life sciences companies regarding regulation by and engagement with the FDA during the COVID-19 pandemic.

Maura received her J.D., with honors, from the George Washington University Law School where she was an associate of The George Washington International Law Review. She received her B.A. from the University of Virginia where she was a Jefferson Scholar.

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Madeleine Giaquinto, J.D.

Director, Regulatory Affairs

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Kalah Auchincloss, J.D., M.P.H.

Executive Vice President, Regulatory Compliance & Deputy General Counsel

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Samantha Eakes

Vice President, Regulatory Affairs

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Elizabeth Oestreich

Senior Vice President, Regulatory Compliance

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Cynthia Schnedar

Principal, Regulatory Compliance

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John Taylor

President and Principal, Compliance and Regulatory Affairs

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Maura M. Norden, J.D.

Executive Vice President, Medical Devices and Combination Products & General Counsel

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