Greenleaf Health is expanding its regulatory policy services to further support the needs of clients. A dedicated Regulatory Policy Services Team will be guided by long-time Greenleaf team member, Kate Cook, who will assume a new leadership role at the firm as Principal, Regulatory Policy.
“Since joining Greenleaf more than five years ago, Kate has been a source of both immense regulatory knowledge and exceptional strategic skill. Her inherent leadership abilities, which were well known at the FDA, will guide her team as they build on the valuable regulatory policy services our clients seek,” said John Taylor, President, Greenleaf Health, Inc.
Regulatory Policy Services
Greenleaf’s regulatory policy services are designed to support the needs of large and small clients as they navigate FDA regulations and regulatory policies. The firm’s team of experts works cross-functionally to provide a full-service engagement that assists pharmaceutical and biotechnology companies, medical device manufacturers, patient groups, trade associations, and other stakeholders in communicating effectively about FDA regulatory policy issues and in understanding, implementing, and complying with the FDA’s regulatory programs.
With decades of experience in senior positions at the FDA and throughout industry, Greenleaf’s Regulatory Policy Services Team offers unmatched insight on pre- and postmarket regulatory policy issues, product designations, expedited programs, regulatory intelligence, and scientific policy.
Greenleaf experts draw on their extensive institutional knowledge of the FDA’s overarching regulatory approach, as well as deep and granular expertise regarding FDA regulation of medical product types across the product lifecycle, to provide the following services:
- Assistance with designing and implementing regulatory policy strategies to effectively advance priorities
- Guidance on policy issues related to development programs, combination products, submissions for marketing authorization, and the postapproval phase
- Stakeholder engagement and alliance development to achieve regulatory policy goals
- User fee negotiation support, impact assessment, and program development
- Strategic regulatory guidance for sponsors seeking access to FDA programs and designations, including orphan drug, breakthrough therapy, RMAT, and other expedited pathways
- Regulatory landscape analysis and advice on incorporating novel tools and approaches into development programs
About Kate Cook
Kate joined Greenleaf in 2016 following a distinguished career of more than 20 years at the FDA. In her new role as Principal of Regulatory Policy, Kate will build on the experience she gained over the last five years as Executive Vice President of Drug and Biological Products, coupled with her extensive FDA institutional knowledge, to grow the firm’s services focused on FDA regulatory policies and programs.
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 the Center for Devices and Radiological Health (CDRH) and Senior Advisor in the FDA’s Center for Biologics Evaluation and Research (CBER). During her FDA tenure, Kate had a pivotal role in the development and implementation of significant policies, regulations, and strategic initiatives related to drugs, biological products, and medical devices. Learn more about Kate Cook.
ABOUT GREENLEAF
Greenleaf Health provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies researching, developing, and manufacturing innovative solutions to pressing global public health challenges. The firm includes former leaders and regulatory professionals from the FDA, Capitol Hill, top global pharmaceutical and medical device companies, leading law firms, and the top U.S. biotechnology trade organization. Greenleaf’s blend of former FDA officials and industry experts provides a unique set of capabilities when advising entities regulated by the FDA.
Greenleaf is a regulatory consulting firm and does not provide legal advice or legal services.