Biologics Consulting Group, Inc. is the leading regulatory consulting firm in product development and regulatory strategy for Biologics, Drugs, and Medical Devices. For over 20 years, Biologics Consulting Group has supported clients in the preparation and review of CBER, CDER and CDRH regulatory applications, product development strategies, Quality (or CMC) requirements, pre-clinical and clinical study designs, GLP/GCP/GMP audits, and strategic business planning.
BCG advises a global client base in navigating the dynamic areas of product development and regulatory strategy. We have knowledge and contemporary experience with regulatory pathways and can provide the requisite preclinical, clinical, quality, analytical, manufacturing support to increase your chances for success.
View More Consultants »
Dr. Jinjie Hu and Dr. Mark Thornton have collaborated to form a new perspective on companion diagnostics development in oncology. Since FDA regulatory frameworks have historically followed a "body part" approach in oncology, companion diagnostics are introducing new frontier in regulatory science that sponsors must manage with the FDA through scientific engagement and regulatory strategy. Read more