*Heather Hatcher is not licensed to practice law. Her activities are directly supervised by members of the firm licensed to practice law in the firm’s Winston-Salem office.
Heather joined the firm as a Regulatory Scientist. She has extensive experience in Regulatory Affairs and as a basic and clinical research scientist. She effectively guides clients through the complex regulatory landscape governed by the US Food and Drug Administration (FDA) toward market authorization. In addition to advising clients on early regulatory strategy and product development issues, Heather prepares regulatory submissions to the FDA for drugs, biologics, and medical devices. Her experience includes the preparation of pre-submissions, initial Investigational New Drug (IND) and Investigation Device Exemptions (IDE) applications, annual progress reports, and FDA meeting requests.
Heather also helps clients prepare responses to the FDA and provides regulatory advice on best practices for Phase I/Phase II clinical trials, standard operating procedures and protocols for Good Manufacturing Practices (GMP), and quality control testing for stem cell therapy and biomaterials. She has experience researching predicate devices for 510(k) submissions, and preparing requests for Humanitarian Use Device (HUD) and Humanitarian Device Exemption (HDE).
Before joining Womble Bond Dickinson, Heather worked in academic research and research administration at Wake Forest Baptist Medical Center for 12 years.
- Panelist, “How to Navigate the FDA Approval Process and Other Regulatory Issues”, SCBIO, December 1, 2020
- "Regenerative Medicine and Advanced Therapies (RMATs)", Introduction to Biologics and Biosimilars Law and Regulation, Food and Drug Law Institute, October 14, 2020