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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.

 

UPCOMING SPEAKING ENGAGEMENTS

 

Seventh Annual Next Generation DX Summit

August 19, 2015
Washington, DC
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Session Title: Establishing Reference Methods to Evaluate New Biomarkers for Infectious Disease

Speaker: Kate Simon, Ph.D.

Dr. Simon has expertise in in vitro diagnostic device regulatory strategy and requirements.
 

American Association of Pharmaceutical Scientists- Annual Meeting

October 28, 2015
Orlando, FL
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Session: Essentials of Stability Testing for Phamraceutical Scientists: A Live Session of Stability Testing 101 E-Learning Course

Speaker: Nanda Subbarao, Ph.D.

Dr. Subbarao has expertise in analytical CMC technical and regulatory requirements and R&D/commerical GLP/GMP quality systems for drugs and neuroceuticals.
 

2015 Eastern Anaylitcal Symposium and Exposition

November 17, 2015
Somerset, NJ
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Session: Lifecycle Management of Analytical Validation of Pharmaceutical Products

Speaker: Nanda Subbarao, Ph.D.

Dr. Subbarao has expertise in analytical CMC technical and regulatory requirements and R&D/commerical GLP/GMP quality systems for drugs and neuroceticals.
 

2015 PDA/FDA Vaccines Conference

December 1, 2015
Bethesda, MD
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Session: Analytical Methods for Vaccines

Speaker: Nanda Subbarao, Ph.D.

Dr. Subbarao has expertise in analytical CMC technical and regulatory requirements and R&D/commerical GLP/GMP quality systems for drugs and neuroceuticals.
   
   
   
   
   
   

 

 
 
 
 
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