Greenleaf Health, Inc. (Greenleaf) today announced that David Elder and Kate Cook, former senior officials at the U.S. Food and Drug Administration (FDA) have joined the firm. The addition of Elder and Cook to Greenleaf’s team of experts expands the firm’s unmatched regulatory expertise.
Greenleaf is guided by experts with a combined total of more than 200 years of FDA experience. Elder and Cook join 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. Daniel Schultz, former Director of FDA’s Center for Devices and Radiological Health (CDRH); Michael Chappell, former Associate Commissioner for Regulatory Affairs; Heather Rosecrans, former Director of CDRH's 510(k) staff; Joe Griffin, former Associate Director of Policy Development for FDA’s Center for Drug Evaluation and Research (CDER); Linda Carter, former Associate Director of CDER's Office of Evaluation I; Cynthia Schnedar, former Director of CDER’s Office of Compliance; Taryn Fritz Walpole, former FDA Deputy Chief of Staff; and Stephen Mason, former Assistant Commissioner for Legislation. Greenleaf’s blend of former FDA officials and industry experts provide a unique set of capabilities when advising entities regulated by the FDA.
David Elder, Executive Vice President, Regulatory Compliance
A 23-year veteran of FDA and the U.S. Public Health Service, David Elder served as a senior FDA official with prominent roles in domestic and foreign inspections, recalls and emergencies and compliance actions.
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. In 2003, David was selected as the Director of FDA’s Office of Enforcement, a position he held for the next six years. In this senior position, David led the Office with responsibility for agency enforcement policy, agency recall policy, operations and enforcement strategy, and case review. In 2009, David transferred to the Office of Regional Operations where he was responsible 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 FDA’s Associate Commissioner of Regulatory Affairs.
At Greenleaf, David joins the firm’s Product Quality, Manufacturing & Compliance group, where he provides strategic guidance and support to pharmaceutical and medical technology companies in areas including: strengthening corporate quality systems, developing compliance strategies, ensuring inspection readiness and assisting industry clients and legal counsel in developing and communicating corrective action plans and performing due diligence activities.
Kate Cook, Executive Vice President, Drug and Biological Products
Kate Cook joins Greenleaf following a distinguished career of more than 20 years at the FDA. During her FDA tenure, Kate provided direction on strategic initiatives related to the regulation of drugs, biological products and medical devices.
Kate’s FDA career began in the Office of Chief Counsel, where she served for more than 15 years as a legal counsel on FDA issues related to such medical products as biosimilars, vaccines, allergenics, human tissue and cellular products, blood products, medical devices and combination products. She also provided legal guidance on issues related to human subject protection and advertising and promotion.
Kate’s FDA experience included roles as Associate Director for Regulations and Policy within CDRH and Senior Advisor in FDA’s Center for Biologics Evaluation and Research (CBER). In both roles, Kate played a pivotal role in the development and implementation of policies and regulations applicable to biological products, drugs, combination products and medical devices.
At Greenleaf, Kate joins the firm’s Drug & Biological Products group, where she continues her commitment to public health by providing strategic consulting services and working with clients to bring innovative medical products to patients.
About Greenleaf Health
Greenleaf Health is a full service regulatory consulting firm that provides strategic and technical guidance to pharmaceutical and medical device companies developing and manufacturing innovative solutions to pressing global public health challenges.
For more information on David Elder, Kate Cook and Greenleaf Health, visit greenleafhealth.com.
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Last updated on: 16/11/2016
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