Dr. Atthachai Homhuan is the director of the regulatory affairs department at Tilleke & Gibbins. Atthachai assists chemical, life sciences, pharmaceutical, and biotechnology companies with regard to the preparation and submission of the healthcare product dossiers for registration, including biological products and vaccines, biosimilar products, new chemical entities, medical devices, food and herbal products, cannabis and hemp, cosmetics, and household chemicals. He assists international companies in developing market entry strategies for countries in Southeast Asia. His broad experience allows him to evaluate the feasibility of product registrations, conduct pharmaceutical and medical device plant audits/due diligence, and coordinate pre-clinical and clinical trials in accordance with international guidelines and standards. Atthachai also reviews healthcare product labeling/claims/advertisements for food products, cosmetics, medical devices, cannabis and hemp, and drug products in Thailand and other Southeast Asian countries.
In addition, he also assists the life sciences industry 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 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 the 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 FICPI South East Asian Drafting Training Course, enabling him to prepare patent applications and claims.
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