BIOLOGICS CONSULTING GROUP, INC.
We Deliver Unparalleled Expertise
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.
Today’s Challenges Are Tomorrow’s Opportunities
Biologics Consulting Group, Inc. 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.
Our Difference is Our Consultants
The Biologics Consulting Group team is comprised of over 40 consultants with experience as FDA reviewers and senior supervisors, certified FDA inspectors, and senior leaders from the biotechnology industry. Our team brings unparalleled expertise in FDA regulations, with over 20 consultants having prior positions in the Agency and nearly constant contact with multiple review divisions at CBER, CDER, and CDRH. Our understanding of the FDA enables us to bridge the tough decisions to find the right balance of business, scientific, and regulatory in product development.