Regulatory

Our core Becker Consulting™ expertise is the successful design and implementation of strategies to support marketing approval of innovative products regulated by the Food and Drug Administration (FDA). Our work is always based in the latest science, a critical starting point to any FDA approach.

Members of the firm have over 20 years of experience providing strategic marketing approval support in a variety of specialized practice areas, including:
  • Medical Devices and Pharmaceuticals
  • Combination Products
  • In Vitro Diagnostics
  • Cosmetics
  • Food and Consumer Products
  • Tobacco Products
 Regulatory Services:
  • Marketing approval strategy
  • Preparation of submissions:  PMA, IDE, 510(k), IND, NDA, BLA, DMF, and More
  • FDA negotiations and appeals
  • Advisory Committee and Panel Meeting support, including:
  • Strategic development of Meeting Requests, Panel Packs, Expert Reports, and Sponsor Presentations
  • Identification and management of subject-matter experts
  • Coordination of mock panels, preparation workshops, and other practice sessions
  • Guidance on the latest regulatory issues and requirements.