Regulatory Sciences

B2S Consulting offers regulatory and quality consulting services applicable to clinical drug development for the pharmaceutical and biotechnology industries.

B2S Consulting has extensive experience in a wide range of areas related to regulatory interactions, including:

  • Site inspection support
  • Responding to FDA questions
  • Provision of planning and regulatory strategy (IND and NDA submissions)
  • Supporting preparation and presentation for all types of FDA meetings (e.g., pre-IND, EOP2, pre-NDA)
  • Providing guidance for 505(b)(2) and biosimilar submissions
  • Interpret FDA policies and guidelines
  • Develop U.S. labeling (e.g., physican and patient package inserts, cartons and vials)
  • Direct FDA Advisory Committee preparations, briefing documents and presentations
B2S Life Sciences