NDA Partners LLC: A Development Partner to Biopharmaceutical Investors and Companies

Gregory Coulter, PhD

Practice Area Focus

  • Drugs
  • Orphan Drugs
  • CMC
  • Manufacturing QA
  • Regulatory Compliance

Biography

Dr. Greg Coulter, PhD, joined NDA Partners as an Expert Consultant in 2016. Dr. Coulter is a pharmaceutical development executive with more than twenty years of experience in GLP, GMP, and GCP regulated drug development and manufacturing. He is an experienced program manager and has planned and led the construction, equipping, hiring, and expansion of two GLP-compliant laboratories for a global CRO.

Dr. Coulter was formerly the Director of Formulations and Analytical Services at SNBL USA, Ltd.; Manager, cGMP Manufacturing at Cell Therapeutics, Inc.; Senior Process Chemist at Synthetech Inc.; and President of CTM Solutions, LLC. He has extensive experience in drug substance characterization, drug product formulation, manufacturing scale-up, regulatory compliance, quality assurance, and CMC regulatory writing, and is a specialist in development of liquid and solid oral formulations, liquid and lyophilized injectable formulations, and clinical supplies manufacturing. During his professional career, Dr. Coulter has provided operational and regulatory CMC guidance for virtual, start-up, development stage, and commercial organizations.

He is a member of several professional organizations including the American Association of Pharmaceutical Scientists (AAPS); Global Clinical Supplies Group (GCSG); and the Organization of Regulatory and Clinical Associates (ORCA).