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