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Regulatory & Licensing Services
From dossier gap analysis and registration to variations, advertising approval, and manufacturing / import / storage facility licences.
Regulatory and licensing success in Thailand requires deep insight into local legal frameworks, early strategic planning, and expert execution. We deliver end-to-end regulatory services powered by highly experienced healthcare compliance specialists.
Our coverage spans both strategic regulatory capabilities and technical compliance & facility licensing.
What's included
Strategic Gap Analysis & Pre-Submission Audits
We execute precision-driven pre-submission simulations to identify dossier deficiencies and regulatory risks, ensuring your technical dossier (ACTD/ICH-CTD) is compliant and review-ready prior to Thai FDA submission.
End-to-End Regulatory Lifecycle Management
Comprehensive regulatory management spanning dossier preparation, initial registrations, post-approval variations, and advertisement approvals across broadcast, print, and digital media for pharmaceuticals, medical devices, food/dietary supplements, herbal products, and cosmetics.
GMP Inspection & Facility Licensing Consultancy
Expert consultancy for Thai FDA and PIC/S GMP inspections, including readiness assessments, mock audits, corrective and preventive action (CAPA) planning, and onsite support.
Comprehensive Facility Licensing (Manufacturing / Importation / Storage)
Pharmaceuticals & medical devices — manufacturing plants, import entities and specialised warehouses · Food, supplements & cosmetics — structural compliance planning and licence acquisition to national hygienic standards · Hazardous substances (medical use) — clearance and licensing for manufacture, import, storage and commercial possession.
Our Product Registration Portfolios
Pharmaceuticals (innovative drugs, biologics, generics, biosimilars) · Medical devices across all risk classifications · Food & dietary supplements · Cosmetics · Herbal products · Hazardous substances.