Regulatory And Research Services for Suriname

πŸ‡ΈπŸ‡· Regulatory and Research Services for Suriname – Dossier-DMF Services @ Zoesoe Exports Pvt Ltd

We, Zoesoe Exports Pvt Ltd, specialize in providing end-to-end regulatory and research solutions to pharmaceutical, nutraceutical, herbal, and cosmetic companies aiming to enter the Surinamese market.
Our services ensure full compliance with the Ministry of Health Suriname – Department of Pharmaceutical Affairs (DPA) regulations, national standards, and international ICH/WHO guidelines.

πŸ“˜ Regulatory Services for Suriname
Regulatory & Product Registration Support – Suriname
We assist pharmaceutical, nutraceutical, and cosmetic companies at every stage of regulatory submission and product approval in Suriname, ensuring a smooth market entry and full compliance with DPA guidelines.

πŸ“˜ Product Registration Services
β€’ Preparation and submission of export registration dossiers for prescription (Rx) and OTC products.
β€’ Registration support for Herbal, Ayurveda, Nutraceutical, Veterinary, and Cosmetic products.
β€’ Guidance on local labeling, packaging requirements, and product information leaflets.

πŸ“— Drug Master File (DMF) Services
β€’ Compilation of CTD/ACTD-compliant DMFs for APIs intended for Suriname registration.
β€’ Support in API regulatory documentation, including quality, safety, and stability data.

βš—οΈ Bioequivalence (BE) Study Support
β€’ Design and coordination of BE studies in DPA-approved CROs.
β€’ Preparation of complete BE study reports in accordance with WHO and Suriname regulatory requirements.

πŸ”¬ Analytical Method Validation (AMV) Services
β€’ Validation of analytical methods as per ICH Q2(R2) guidelines.
β€’ Preparation of AMV documentation for regulatory submission and routine QC support.

🧾 Regulatory Consultancy & Compliance
β€’ Comprehensive regulatory guidance for export or local market entry in Suriname.
β€’ Assistance with import/export permissions, DPA inspections, and post-approval compliance.
β€’ Regular updates on DPA and WHO regulatory changes to ensure continuous product compliance.

πŸ§ͺ Research & Development (R&D) Services – Suriname
Our R&D services support your product development, validation, and quality assurance activities in compliance with Suriname’s DPA and international standards.

πŸ’Š Formulation Development
β€’ Development of tablets, capsules, syrups, powders, and injectables.
β€’ Optimization for stability, bioavailability, and efficacy suited to regional conditions.

🧫 Analytical R&D Services
β€’ Assay, dissolution, impurity profiling, and stability testing.
β€’ Quality control method development and routine analytical testing.

πŸ“‘ Product Development Reports (PDRs)
β€’ Preparation of comprehensive PDRs for regulatory submission.
β€’ Inclusion of manufacturing process, QC methods, and stability data in line with DPA requirements.

πŸ§β€βš•οΈ Clinical Trial & Toxicology Support
β€’ Preparation of clinical trial protocols and final study reports.
β€’ Toxicological evaluation in compliance with OECD and DPA guidelines.

🌏 Why Choose Us for the Surinamese Market
β€’ Experienced Team – Experts in DPA, WHO, and ICH regulatory frameworks.
β€’ End-to-End Support – From formulation development to market registration and post-approval compliance.
β€’ Global Exposure – Proven experience across ROW, ASEAN, US, and EU markets.
β€’ Timely Submissions – Streamlined processes ensuring faster approvals.
β€’ Custom Solutions – Tailored strategies for your product type, market, and regulatory pathway.

πŸ“˜ Regulatory & Dossier Documentation – Suriname
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βš—οΈ Bioequivalence & Analytical Studies – Suriname
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πŸ§ͺ Technology Transfer & Safety – Suriname
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