Regulatory And Research Services for Philippines
🇵🇭 Regulatory and Research Services for Philippines – 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 Philippines market.
Our services ensure full compliance with the FDA Philippines, under the Department of Health (DOH), as well as WHO and ICH guidelines.
📘 Regulatory Services for Philippines
Regulatory & Product Registration Support – Philippines
We assist pharmaceutical, nutraceutical, and cosmetic companies in dossier preparation, submission, and product registration with FDA Philippines, 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 FDA Philippines regulations.
📗 Drug Master File (DMF) Services
• Compilation of CTD/ACTD-compliant DMFs for APIs intended for registration in Philippines.
• Support in preparing quality, safety, and stability documentation in line with FDA Philippines and ICH standards.
⚗️ Bioequivalence (BE) Study Support
• Design and coordination of BE studies in FDA-approved CROs.
• Preparation of BE study protocols and reports according to WHO and FDA Philippines 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 Philippines market.
• Assistance with import/export licensing, FDA Philippines inspections, renewals, and post-approval compliance.
• Continuous updates on FDA Philippines regulatory changes to ensure product compliance.
🧪 Research & Development (R&D) Services – Philippines
Our R&D services support formulation development, analytical validation, and quality assurance activities in compliance with FDA Philippines and international standards.
💊 Formulation Development
• Development and optimization of tablets, capsules, syrups, powders, and injectables.
• Stability studies designed for tropical climate conditions of the Philippines.
🧫 Analytical R&D Services
• Assay, dissolution, impurity profiling, and stability testing.
• Analytical method development and transfer to partner laboratories per FDA Philippines requirements.
📑 Product Development Reports (PDRs)
• Preparation of comprehensive PDRs for submission to FDA Philippines.
• Inclusion of formulation, manufacturing, QC, and stability data.
🧍⚕️ Clinical Trial & Toxicology Support
• Preparation of clinical trial protocols, investigator brochures, and final reports.
• Toxicological studies in accordance with OECD and WHO guidelines for FDA Philippines submission.
🌏 Why Choose Us for the Philippines Market
• Experienced Regulatory Experts – Skilled in FDA Philippines, WHO, and ICH regulatory frameworks.
• End-to-End Support – From dossier preparation to post-approval compliance.
• Regional Expertise – Proven success across ASEAN and Southeast Asia 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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