FDA-Regulated Products - Drugs, Biologics, Devices

No matter how much planning goes into development of a new product, including extensive documentation of the safety and efficacy of the product, it is impossible to predict what issues may arise, either during development or once the product is marketed.

IB's partners have had extensive experience in assisting manufacturers of a variety of drug, biologic devices and diagnostics in both pre-market and post-market stages of product development.  IB has assisted clients by:

 

Providing strategic and practical regulatory and product development advice

Developing pre-clinical testing strategies, including protocol design, study placement and monitoring, QA/QC, and preparation of the pre-clinical portions of INDs, NDAs, and BLAs.

Developing clinical trial strategies, including protocol design for Phase I, II, and III.

Interpreting and reviewing clinical trials; prepare NDA and BLA submissions.

Design and interpretation of post-market surveillance strategies.

Preparation of materials for pre-IND meetings with FDA.

Responding to Agency letters and correspondence relating to compliance issues.

Providing regulatory compliance training to the staff of small companies.