|Robert Gadimian earned his Master in Pharmacy degree from the distinguished Uppsala Universit in Sweden and earned Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society (RAPS). He is a Chemistry, Manufacturing, and Controls (CMC) regulatory sciences executive with demonstrated expertise in leading multidisciplinary, cross-functional teams to obtain regulatory approvals to market novel and innovative pharmaceutical drug substances and drug products and is experienced in the management and maintenance of Post-Approval, Life-Cycle regulatory CMC compliance and conformance.Robert is a Regulatory Affairs professional with 20 years of direct and first-hand global Regulatory experience in both Big-Pharma and small biotech companies located in The USA and EU. The experience encompasses the full spectrum of drug-development expertise (pre-IND to marketed products) and has been involved in the development of multiple pharmaceutical products. I have managed the global regulatory challenges associated in drug development and has gained experience in handling a wide range of drug development issues.
In 2016, Robert founded Rafe Pharma with the primary focus to provide strategic, senior level, executive CMC Regulatory Sciences consulting services to the pharmaceutical and biopharmaceutical industries on small molecule Drug Substance and Drug Product dosage form for all CMC regulatory phases during the Investigational New Drug (IND, CTA) development and planning, submission and approval for New Drug Application (NDA, MAA) and for the maintenance of Post-Approval, Life Cycle regulatory CMC Quality Compliance and Conformance.
CEO and Founder