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

Suva B. Roy, PhD

Practice Area Focus

  • Regulatory Strategy
  • CMC Regulatory Affairs
  • FDA Meeting Planning
  • Due Diligence


Suva Roy, PhD, joined NDA Partner as an Expert Consultant in 2013. Dr. Roy is a CMC Regulatory Affairs expert with experience in CMC regulatory strategy, policy development at FDA and in the industry, and with a background in product development.

He served as a Chemist and Supervisory Chemist in the Office of New Drug Chemistry, Division of Anti-infective Drug Products, FDA, where he coauthored the SUPAC-IR guidance, advised SUPAC-MR and SUPAC-SS teams, and contributed to the IR Solid Oral Dosage Form Dissolution Guidance. Dr. Roy was awarded special recognition for his IR Dissolution Guidance, the SUPAC-IR Guidance, and for the Antibiotic Review Team while at the FDA.

Immediately prior to joining NDA Partners, Dr. Roy was the Senior Director, Regulatory Affairs CMC, at Otsuka America Pharmaceutical working primarily with his R&D and Regulatory colleagues in Japan. Before Otsuka he was Director of Regulatory Affairs at Glaxo Wellcome.

Dr. Roy was in R&D prior to his Regulatory Affairs career where he served as a Senior Scientist at Lederle Laboratories and Development Chemist at Dupont Medical Products. He began his career as an Assistant Professor of Industrial Pharmacy at his Alma-mater in Boston, where he taught Graduate Level courses in Unit Operations, Product Stability Testing and Liquid dosage forms.