Regulatory And Research Services for Malaysia
🇲🇾 Regulatory and Research Services for Malaysia – Dossier-DMF Services @ Zoesoe Exports Pvt Ltd
We, Zoesoe Exports Pvt Ltd, specialize in providing comprehensive regulatory and research services for pharmaceutical, nutraceutical, herbal, and cosmetic companies aiming to enter the Malaysia market.
Our solutions ensure complete compliance with the National Pharmaceutical Regulatory Agency (NPRA) under the Ministry of Health (MOH) Malaysia, as well as ICH, WHO, and ASEAN guidelines.
📘 Regulatory Services for Malaysia
Regulatory & Product Registration Support – Malaysia
We assist companies in dossier preparation, submission, and product registration with the NPRA Malaysia, ensuring smooth regulatory approval and market access in full compliance with MOH requirements.
📘 Product Registration Services
• Preparation and submission of registration dossiers for prescription (Rx) and OTC products.
• Registration assistance for Herbal, Traditional, Nutraceutical, Veterinary, and Cosmetic products.
• Guidance on labeling, packaging, and product information leaflets per NPRA standards.
📗 Drug Master File (DMF) Services
• Compilation of CTD/ACTD-compliant DMFs for APIs intended for registration in Malaysia.
• Assistance in preparing quality, stability, and analytical documentation as per NPRA and ICH norms.
⚗️ Bioequivalence (BE) Study Support
• Design and coordination of BE studies in NPRA-approved CROs.
• Preparation of BE protocols, reports, and summaries according to WHO and NPRA requirements.
🔬 Analytical Method Validation (AMV) Services
• Analytical method validation in accordance with ICH Q2(R2).
• Preparation of AMV documentation for submission and internal QC reference.
🧾 Regulatory Consultancy & Compliance
• Complete regulatory guidance for market entry into Malaysia.
• Support with import/export licenses, NPRA inspections, renewals, and post-approval variations.
• Periodic updates on NPRA regulatory framework changes to ensure product compliance.
🧪 Research & Development (R&D) Services – Malaysia
Our R&D services support product development, validation, and analytical quality assurance aligned with NPRA and international standards.
💊 Formulation Development
• Development and optimization of tablets, capsules, liquids, creams, and injectables.
• Stability testing under ASEAN climatic zones suitable for Malaysia’s conditions.
🧫 Analytical R&D Services
• Assay, dissolution, impurity profiling, and stability studies.
• Analytical method development and validation as per NPRA requirements.
📑 Product Development Reports (PDRs)
• Preparation of comprehensive PDRs for NPRA submission.
• Inclusion of formulation, process, and QC data per ASEAN ACTD format.
🧍⚕️ Clinical Trial & Toxicology Support
• Preparation of clinical protocols, investigator brochures, and study reports.
• Toxicology studies compliant with OECD and WHO guidelines for NPRA review.
🌏 Why Choose Us for the Malaysia Market
• Experienced Regulatory Professionals – Skilled in NPRA, ICH, and ASEAN ACTD frameworks.
• Comprehensive Support – From dossier compilation to registration and post-approval assistance.
• ASEAN Region Expertise – Strong background across Malaysia, Indonesia, Thailand, and Vietnam.
• Fast Documentation Turnaround – Ensuring quicker NPRA reviews and approvals.
• Tailored Solutions – Custom strategies for each product type and regulatory pathway.
📘 Regulatory & Dossier Documentation
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⚗️ Bioequivalence & Analytical Studies
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🧪 Technology Transfer & Safety
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