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 repot

Patient or Subject Individual – PK case report form