Select Page

Clinical Drug Development & Regulatory Support

B2S Life Sciences® offers technical, regulatory and quality consulting services applicable to clinical drug development for the pharmaceutical and biotechnology industries.

Our team 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
  • Interpreting FDA policies and guidelines
  • Developing U.S. labeling (e.g., physician and patient package inserts, cartons and vials)
  • Directing FDA Advisory Committee preparations, briefing documents and presentations

In addition to these interactions, B2S Life Sciences® can also assist in the development of necessary pharmacokinetic reports:

  • Stand Alone – suitable for regulatory submission
  • Integrated – suitable for incorporation into full report
  • Patient or Subject Individual – PK case report form