Regulatory Strategy & Support

UBC’s regulatory affairs professionals provide comprehensive services to support biopharmaceuticals, medical devices, and other health products. We work collaboratively with manufacturers to develop innovative, customized, strategic programs that help our clients navigate the regulatory milestones and hurdles associated with the development and commercialization of their products. We provide:

  • Comprehensive regulatory planning to support strategic product development
  • Global regulatory strategy preparation and implementation
  • Regulatory liaison activities (e.g, submissions, meetings)
  • Guidance to support preclinical and clinical research programs
  • Regulatory training

UBC provides a wide array of support services, including medical writing, statistics and programming.

UBC experts have an extensive experience with the U.S. Food & Drug Administration (FDA), the European Medicines Agency (EMA), local European regulatory agencies, and a range of other regulatory agencies and organizations throughout the World.

Our services include:

Filings & Submissions

  • Medical Writing
  • IND Filing
  • NDA/BLA/MAA Authoring
  • Integrated Summaries of Efficacy & Safety

Regulatory Meetings & Representation

  • FDA, EMEA, etc
  • End-of-Phase II Meetings
  • FDA Advisory Committees
Thought Leaders