At Interthai Pharmaceuticals, we provide comprehensive regulatory affairs support designed to streamline product registration and accelerate approvals. Our experienced regulatory team works closely with clients to ensure every submission complies with both Thai FDA requirements and international regulatory standards.
We assist partners across a broad range of therapeutic categories and product types, including pharmaceuticals, Herbal medicines, supplements, and cosmetics. Our end-to-end services cover every stage of the regulatory process—from dossier preparation to post-approval variations.
Tailored support based on each project’s classification, formulation, and target market.
Preparation of ACTD/eCTD dossiers and coordination with Thai FDA and assist submission at other ASEAN authorities.
Assistance in acquiring import licenses and manufacturing permissions for new and existing products.
Handling post-approval updates, renewals, and product life-cycle maintenance.
Compliance checks to ensure product presentation meets local and regional labeling standards.
Continuous engagement or consultation with authorities to expedite communication and resolve queries efficiently.
