General Info

Biologics Consulting Group is a team of consultants who provide national and international regulatory and product development advice on the development and commercial production of biological, drug and device products. It is comprised of regulatory affairs, product manufacturing and testing, toxicology, facility inspection, statistics, program management, and clinical trial design and evaluation experts. The team specializes in the inspection and audit of biologics manufacturing facilities and regulatory activities for drugs, device and combination products. Biologics Consulting Group reviews and evaluates clinical and manufacturing data and assists in clinical trial design, as well as offers guidance on various interactions and meetings. It additionally assists in identifying critical process parameters and preparing appropriate validation studies and prepares process validation-related submissions. The company is located in Alexandria, Va.