Regulatory Affairs Director of Tilleke & Gibbins
Dr. Atthachai Homhuan is the director of the regulatory affairs department at Tilleke & Gibbins. Dr. Atthachai prepares healthcare product dossiers for registration and he helps international companies develop market entry strategies for countries in Southeast Asia. His broad experience allows him to evaluate the feasibility of product registrations, conduct plant audits, and coordinate pre-clinical and clinical trials in accordance with international guidelines and standards. Atthachai also reviews healthcare product labeling for food, cosmetics, medical devices, and drug products in Thailand and other Southeast Asian countries.
Atthachai also assists chemical, life sciences, pharmaceutical, and biotechnology companies to draft and review their patent claims and specifications. He advises patent agents on amending claims and providing responses to office actions. Atthachai frequently drafts counterstatements against opposing parties in trademark and patent applications. His practice also includes advising on pre-litigation and litigation matters involving the life sciences, medical devices, and pharmaceuticals. He has presented before the IP&IT Court as a witness in chemistry and life sciences patent litigation.
Prior to joining the firm, Atthachai was a postdoctoral researcher in Japan and China Taiwan, focusing on stem cell therapies and vaccine development. He applied his technical expertise to the industry when he became a project manager for a Thai vaccine manufacturing company, where he led the firm’s R&D efforts. His industry background also includes serving as a formulation manager at the subsidiary of a well-known American pharmaceutical innovator, where he was a group leader in charge of the company’s R&D and production functions.
Atthachai holds a PhD in Pharmaceutical Technology from Thailand’s Mahidol University, and he frequently lectures on pharmaceutical and chemical patents at universities across Thailand. He has completed the South East Asian Drafting Training Couse, enabling him to prepare patent applications and claims.
Regulatory Affairs Consultant
Kittiya Nopparatrungroj is a consultant in Tilleke & Gibbins’ regulatory affairs team in Bangkok and is a licensed pharmacist in Thailand. She advises and assists international and local clients in the pharmaceutical, medical device, and broader life sciences industries on market entry, obtaining and maintaining marketing authorization licenses, advertising and marketing regulations, and other related regulatory affairs matters. She also regularly prepares and reviews registration dossiers, and evaluates the feasibility of product registrations, advertisements, and labeling material for pharmaceutical products and medical devices.
Kittiya regularly authors articles covering updates of Thai laws and regulations applicable to the pharmaceutical and medical device industries. In addition, she has participated in several seminars and webinars on the same topics.
Kittiya graduated with a bachelor’s degree in Pharmaceutical Science from Mahidol University. During her studies, she completed internships with a local drug manufacturer and a local cosmetics manufacturer in Thailand. She also received a scholarship to intern at the Analytical Chemistry Institute of Johannes Kepler University in Austria, where she conducted research on steroid hormones from placenta extract.