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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

 

Speaker: Kate Simon, Ph.D.

simon_photo Dr. Simon has expertise in in vitro diagnostic device and regulatory strategy and requirements.
August 19, 2015
Washington, DC

Seventh Annual Next Generation DX Summit

  Session Title: Establishing Reference Methods to Evaluate New Biomarkers for Infectious Disease

 

Speaker: Nanda Subbarao, Ph.D.

subbarao_photo Dr. Subbarao has expertise in anyaltic CMC technical and regulatory requirements and R&D/GMP quality systems for drugs and neuroceuticals.
October 28, 2015
Orlando, FL

American Association of Pharmaceutical Scientists-Annual Meeting

  Session Title: Essentials of Stability Testing for Pharmaceutical Scientists: A Live Session of Stability Testing 101 E-Learning Course
November 17, 2015
Somerset, NJ

2015 Eastern Anaylitcal Symposium and Exposition

  Session Title: Lifecycle Management of Analytical Validation of Pharmaceutical Products
December 1, 2015
Bethesda, MD

2015 PDA/FDA Vaccines Conference

  Session Title: Analytical Methods for Vaccines
   

Speaker: Christina Vessely, Ph.D.

vessely_photo Dr. Vessely comes to BCG with over 17 years of experience in the areas of analytical and formulation development within the biotechnology industry.
August 24, 2015
Brasilia, Brazil

CMC Strategy Forum Latin America

  Session Title: Technology Transfer for Biopharmaceuticals
September 11, 2015
Philadelphia, PA

Analytics for Biologics

  Session Title: Demonstrating Comparability and Similarity on a Small Company Budget
   

 

 
 
 
 
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