Rochelle, Virginia (March 2, 2017) – NDA Partners Chairman Carl Peck, MD, announced today that Greg Coulter, PhD, a pharmaceutical development executive with more than twenty years of experience in GLP, GMP, and GCP regulated drug development and manufacturing has joined the company as an Expert Consultant. 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.
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 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’s extensive experience in drug product formulation, process development, scale-up, and manufacturing, along with his expertise in clinical packaging, labeling, and distribution logistics for global clinical trials, make him an excellent addition to our Expert Consultant team,” said Dr. David Savello, Partner and Manager, Product Quality & CMC Practice. “We are pleased to welcome him to NDA Partners and introduce him to our clients.”
Dr. Coulter earned his PhD in Biological Chemistry and MSc in Organic Chemistry from University of Guelph, Canada, and his BSc, Hon. in Biochemistry from Bishop’s University, Canada.
About NDA Partners
NDA Partners is a strategy consulting firm specializing in expert product development and regulatory advice to the medical products industry and associated service industries such as law firms, investment funds and government research agencies. The highly experienced Principals and Premier Experts of NDA Partners include three former FDA Center Directors; the former Chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK; an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, expert consulting, high-impact project teams, and virtual product development teams.
Earle Martin, Chief Executive Officer