REGULATORY CONSULTING

From FDA meeting preparation to new drug application submission, CCSF has the relevant regulatory expertise to guide sponsors through the entire drug, device, and diagnostic approval process. Our regulatory consulting services include:

 

  • FDA meeting preparation

  • Scientific/academic representation at FDA (IND, IDE, NDA)

  • Assistance with CDISC compliance

  • Filing IND, IDE, NDA

  • Full suite of management systems for site regulatory affairs

 

With both industry and FDA advisory committee experience, our thought leaders deliver impactful regulatory insight for sponsors at all stages of drug, device, and diagnostic development.
 

Dr. Marvin Konstam

  • Former member of FDA Cardiovascular and Renal Drugs Advisory Committee [4 years]

  • Former Senior Adviser, Division of Cardiovascular Diseases, National Heart Lung and Blood Institute

  • Former Chief Medical Officer, Heart Failure Biotechnology Firm

 

Dr. James Udelson

  • Former member of FDA’s Medical Imaging Drug Advisory Committee [4 years]

  • Former ad-hoc Member, FDA Cardiovascular and Renal Drugs Advisory Panel, Peripheral and Central Nervous System Advisory Panel

 

Curious how we can help you navigate your innovations from bench to bedside? Request a capabilities presentation, and hear it directly from our experts.

 

CARDIOVASCULAR CLINICAL SCIENCE FOUNDATION

Experts You Know. Results You Trust. 

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CONTACT US

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P: (617) 423-7999 | F: (617) 423-9766 | E: Info@ccstrials.com

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