Regulatory And Research Services for Singapore
🇸🇬 Regulatory and Research Services for Singapore – 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 Singapore market.
Our services ensure full compliance with the Health Sciences Authority (HSA) Singapore, as well as WHO and ICH guidelines.
📘 Regulatory Services for Singapore
Regulatory & Product Registration Support – Singapore
We assist pharmaceutical, nutraceutical, and cosmetic companies in dossier preparation, submission, and product registration with HSA Singapore, 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 HSA Singapore regulations.
📗 Drug Master File (DMF) Services
• Compilation of CTD/ACTD-compliant DMFs for APIs intended for registration in Singapore.
• Support in preparing quality, safety, and stability documentation in line with HSA Singapore and ICH standards.
⚗️ Bioequivalence (BE) Study Support
• Design and coordination of BE studies in HSA-approved CROs.
• Preparation of BE study protocols and reports according to WHO and HSA Singapore 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 Singapore market.
• Assistance with import/export licensing, HSA Singapore inspections, renewals, and post-approval compliance.
• Continuous updates on HSA Singapore regulatory changes to ensure product compliance.
🧪 Research & Development (R&D) Services – Singapore
Our R&D services support formulation development, analytical validation, and quality assurance activities in compliance with HSA Singapore and international standards.
💊 Formulation Development
• Development and optimization of tablets, capsules, syrups, powders, and injectables.
• Stability studies designed for Singapore’s tropical climate conditions.
🧫 Analytical R&D Services
• Assay, dissolution, impurity profiling, and stability testing.
• Analytical method development and transfer to partner laboratories per HSA Singapore requirements.
📑 Product Development Reports (PDRs)
• Preparation of comprehensive PDRs for submission to HSA Singapore.
• 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 HSA Singapore submission.
🌏 Why Choose Us for the Singapore Market
• Experienced Regulatory Experts – Skilled in HSA Singapore, 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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