Charles G. Chavdarian

Dr. Charles G. Chavdarian is an industry consultant specializing in Pharmaceutical Research & Development, Analytical R&D, Formulation/Manufacturing, QA/QC, and Regulatory CMC. He was formerly the Executive Director of Analytical Sciences & Regulatory CMC at Dow Pharmaceutical Sciences, Inc., Petaluma, California. He held earlier management positions at Syntex Corp., Penederm Inc., ALZA Corp., Cellegy Pharmaceuticals, and InSite Vision. He has worked in the pharmaceutical industry for over 30 years, and earlier in the chemical industry. His pharmaceutical expertise spans nearly every dosage form including solid oral, parenteral, topical (dermatological and ophthalmic), and transdermal, and also includes commercial Rx, OTC, and personal care products. Dr. Chavdarian received his B.S. degree in Chemistry from the University of Michigan, Ann Arbor, and his Ph.D. degree in Organic Chemistry from the University of California, Berkeley, followed by a postdoctoral appointment in Pharmaceutical Chemistry at the University of California, San Francisco Medical Center. He is the author of over 35 technical publications and patents. His strong technical background includes organic and analytical chemistry, analytical method development and validation, formulation development and manufacturing support (APIs and drug products), technology transfer, bioanalytical studies, quality control testing, stability testing, management of stability facilities and studies, and QA auditing of GMP laboratories and manufacturing facilities. He has also worked as a project manager and as a business development representative with client companies, and has performed due diligence audits/inspections. Dr. Chavdarian has extensive experience with regulatory CMC where he has led technical teams involved in the design and implementation of Phase 1 through 4 stability programs, and the compilation and authorship of drug substance and drug product CMC sections for regulatory submissions (i.e., e-CTDs), both domestically and internationally (IND, NDA, ANDA, NDS, CTA, IMPD, MAA). In addition, Dr. Chavdarian has interacted first-hand with regulatory agencies (FDA, Health Canada, Europe) on many occasions (pre-Phase 1 and Phase1 – Phase 3 Guidance meetings, Pre-Approval Inspections), and has successfully worked on many approved drug applications – e.g., NDA, NDS, and ANDA submissions. Dr. Chavdarian has been a speaker at several technical workshops and conferences, including a national webinar on topical drug product development.