Baker McKenzie’s Regulatory Affairs Services Department (RASD) advises clients on how to satisfy regulatory obligations with respect to the launch of products into the Thai market. This initiative was designed to position clients at a comparative strategic advantage and enhance their opportunities for success in Thailand’s growing food, biotech, pharmaceutical and healthcare sectors.
The Baker McKenzie RASD team consists of five professionals trained in food science, pharmaceutical science, and medical science, who bring decades of industry-specific knowledge, understanding, and experience to bear for clients in this hyper-competitive and closely regulated industry sector.
- Processing product registration applications with the Food and Drug Administration (“FDA”) for foods, pharmaceuticals and biologics, veterinary medicine, medical devices, cosmetics, and hazardous substances
- Processing manufacturing license and product registration applications
- Submittal of Safety Monitoring Program data of new drugs to FDA for unconditional approval and on-going pharmacovigilance to ensure that our client’s products are able to remain on the market
- Quality Assurance and ISO9000 Factory Management, including advice on setting up local manufacturing facilities that are GMP, ISO, or HACCP compliant
- Processing import/export licenses and permit applications for exempted products
- Processing product advertisement review and applications
- Providing comprehensive compliance advice and strategies regarding safety and drug laws, consumer and environmental protection, labeling requirements, and import/export laws
- Providing comprehensive, coordinated, ASEAN-specific advice and ASEAN-regulatory approval services
- Full service patent and trademark services, including trade secrets and strategic advice, portfolio management, licensing & registration, and all forms of related litigation
- Regulatory audit