Rochelle, Virginia (May 3, 2018) – NDA Partners Chairman Carl Peck, MD, announced today that Mark D. Weiss, MS, MA, a regulatory CMC expert and former Principal Scientific and Technical Writer at Purdue Pharma, has joined the firm as an Expert Consultant.
Mr. Weiss is an expert in managing and writing complex submissions and regulatory documentation, including CTD and eCTD documentation, and source documentation that conforms to the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and International Conference on Harmonisation (ICH) requirements. His experience also includes formulations development and troubleshooting, batch record development and preparation, analytical methods development, validation, troubleshooting, and scientific and technical writing. He has consulted in a wide variety of CMC-related and other capacities for companies such as Juno Biotherapeutics, TherapeuticsMD, Pfizer Biotech, Taiho Oncology, and Ipsen Biomeasure. In his early career, he was a Pharmaceutical Chemist and Pharmaceutical Formulationist, Analytical Development Chemist, and Medical Writer at Lederle Laboratories.
“Mr. Weiss’ expertise in managing, writing, and preparing complex submissions and regulatory documentation, including CTD and eCTD submissions that conform to FDA, EMA, and ICH requirements, will greatly benefit our clients throughout the regulatory process,” said Dr. Peck. “We are pleased to welcome him to NDA Partners.”
Mark D. Weiss earned a Master of Science in Specialized Journalism from Polytech Institute of New York University, a Master of Arts in Chemistry from Binghamton University, New York, and a Bachelor of Science in Chemistry from Clarkson University, New York. He is a member of the American Medical Writers Association and the American Chemical Society.
About NDA Partners
NDA Partners is a life sciences management consulting firm focused on providing product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide. 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 management of client product development programs.
Earle Martin, Chief Executive Officer