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Biologics

Biologics

 
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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.

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OUR PERSPECTIVES

pieGraphicToday’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.

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OUR ADVANTAGE

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.

 

WE ARE HIRING

Biologics Consulting Group, Inc. is seeking to hire a subject matter expert for a nonclincial pharmacology/toxicology Senior Consultant position with at least 5 years of experience with FDA and/or industry. Please visit our Careers page to learn more about the position and to submit your resume if interested.

 

 
 
 
 
BIOLOGICS CONSULTING GROUP, INC.
400 N. Washington Street, Suite 100, Alexandria, Virginia 22314
Toll: 1 (703) 739-5695 . US Toll Free: 1 (800) 485-0106 . Fax: 1 (703) 548-7457