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Ravi Pinkoh is a consultant in Tilleke & Gibbins’ regulatory affairs team in Bangkok. Ravi assists clients with various regulatory matters pertaining to healthcare innovations in medicinal products, medical devices, food, herbal products, and hazardous substances. He also advises clients on Good Manufacturing Practice (GMP) guidelines, Good Storage and Distribution Practices (GSDP), and Good Clinical Practice (GCP) standards, and assists clients with the maintenance and amendment of marketing authorization throughout the products’ lifecycle. With his expert knowledge of the registration and regulatory requirements of the Thai Food and Drug Administration, Ravi is able to help clients in the life sciences industry stay ahead of potential regulatory risks regarding medicinal products, medical devices, food, herbal products, and other related products.
Prior to joining Tilleke & Gibbins, Ravi was a regulatory affairs associate in various pharmaceutical companies in Thailand, where he handled the registration and variation of healthcare products with the relevant authorities and provided regulatory maintenance for medicinal products throughout their life cycle. He also worked for these companies as a clinical study administrator, responsible for supporting the coordination and administration of clinical studies from initiation to closeout.
Ravi graduated with a bachelor’s degree (Doctor of Pharmacy, DPharm) from Chulalongkorn University. Ravi holds a pharmacist license from the Pharmacy Council of Thailand and is a member of the Regulatory Affairs Pharmacy Association of Thailand (RAPAT).
- Prepared applications and reviewed related documents for product approval licenses and variations for drugs and medical devices, in compliance with Thai FDA regulations.
- Assisted local and international pharmaceutical companies in advising on overseas good manufacturing practice certification (GMP clearance) for medicinal and herbal product registration.
- Advised various companies on obtaining product licenses and manufacturing/import licenses for food, herbal products, and products containing hazardous substances, and assisted with product labeling, product claims, and registration dossiers for approval by the FDA and other relevant authorities in Thailand.
- Provided companies with critical background knowledge on operational considerations in specialized pharmaceutical fields, such as medicinal chemistry or medicine manufacturing, to support intellectual property teams in performing freedom-to-operate (FTO) analyses.
- Advised on product registration and other requirements for food and herbal products containing kratom and cannabis derivatives.