Regulatory And Research Services for Thailand
🇹🇭 Regulatory and Research Services for Thailand – Dossier-DMF Services @ Zoesoe Exports Pvt Ltd
We, Zoesoe Exports Pvt Ltd, specialize in providing end-to-end regulatory and research services for pharmaceutical, nutraceutical, herbal, and cosmetic companies aiming to enter the Thailand market.
Our services ensure full compliance with the Thai FDA, under the Ministry of Public Health (MOPH), as well as WHO and ICH guidelines.
📘 Regulatory Services for Thailand
Regulatory & Product Registration Support – Thailand
We assist pharmaceutical, nutraceutical, and cosmetic companies in dossier preparation, submission, and product registration with Thai FDA, ensuring smooth market access and full regulatory compliance.
📘 Product Registration Services
• Preparation and submission of registration dossiers for prescription (Rx) and OTC products.
• Registration support for Herbal, Traditional, Nutraceutical, Veterinary, and Cosmetic products.
• Guidance on labeling, packaging, and product information leaflets according to Thai FDA regulations.
📗 Drug Master File (DMF) Services
• Compilation of CTD/ACTD-compliant DMFs for APIs intended for registration in Thailand.
• Support in preparing quality, safety, and stability documentation in line with Thai FDA and ICH standards.
⚗️ Bioequivalence (BE) Study Support
• Design and coordination of BE studies in Thai FDA-approved CROs.
• Preparation of BE study protocols and reports according to WHO and Thai FDA requirements.
🔬 Analytical Method Validation (AMV) Services
• Validation of analytical methods in compliance with ICH Q2(R2).
• Preparation of AMV documentation for regulatory submission and routine QC.
🧾 Regulatory Consultancy & Compliance
• Strategic regulatory guidance for entry into the Thailand market.
• Assistance with import/export licensing, Thai FDA inspections, renewals, and post-approval compliance.
• Continuous updates on Thai FDA regulatory changes to ensure product compliance.
🧪 Research & Development (R&D) Services – Thailand
Our R&D services support formulation development, analytical validation, and quality assurance activities in compliance with Thai FDA and international standards.
💊 Formulation Development
• Development and optimization of tablets, capsules, syrups, powders, and injectables.
• Stability studies designed for Thailand’s tropical climate conditions.
🧫 Analytical R&D Services
• Assay, dissolution, impurity profiling, and stability testing.
• Analytical method development and transfer to partner laboratories per Thai FDA requirements.
📑 Product Development Reports (PDRs)
• Preparation of comprehensive PDRs for submission to Thai FDA.
• Inclusion of formulation, manufacturing, QC, and stability data.
🧍⚕️ Clinical Trial & Toxicology Support
• Preparation of clinical trial protocols, investigator brochures, and final reports.
• Toxicology studies according to OECD and WHO guidelines for Thai FDA submission.
🌏 Why Choose Us for the Thailand Market
• Experienced Regulatory Experts – Skilled in Thai FDA, WHO, and ICH regulatory frameworks.
• End-to-End Support – From dossier preparation to post-approval compliance.
• Regional Expertise – Proven success across ASEAN markets.
• Efficient Documentation – Streamlined processes for faster regulatory approvals.
• Custom Strategies – Tailored per product type, regulatory pathway, and market requirements.
📘 Regulatory & Dossier Documentation
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⚗️ Bioequivalence & Analytical Studies
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🧪 Technology Transfer & Safety
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