Regulatory and Research Services for Malaysia – Dossier-DMF Services @Zoesoe Exports Pvt Ltd

Regulatory and Research Services for Malaysia – 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 Malaysia market. Our services are designed to ensure full compliance with National Pharmaceutical Regulatory Agency (NPRA) regulations, Ministry of Health (MOH) Malaysia requirements, and international standards.

Regulatory Services for Malaysia

Regulatory Support – Malaysia

We provide regulatory assistance to pharmaceutical, nutraceutical, and cosmetic companies in Malaysia, as per NPRA guidelines.

Regulatory Affair Services

• Readymade Dossier template for submission purpose

• Preparation of export registration dossiers for prescription (Rx) and OTC products.

• Document support for Herbal, Traditional Medicine, Nutraceutical, Veterinary, and Cosmetic products.

Drug Master File (DMF) Services

• Readymade DMF template for submission purpose

• Compilation of CTD/ACTD-compliant DMFs for APIs intended for Malaysia registration.

• Support in API regulatory documentation covering quality, safety, and stability data.

Bioequivalence (BE) Study Support

• Readymade BE template for submission purpose

• Design and coordination of BE studies in NPRA-approved CROs.

• Full BE report preparation in accordance with WHO and Malaysia regulatory guidelines.

Analytical Method Validation (AMV) Services

• Readymade AMV template for submission purpose

• Validation of analytical methods as per ICH Q2(R2) guidelines.

• Preparation of AMV documentation for regulatory submission and routine QC support.

Regulatory Consultancy & Compliance

• End-to-end regulatory guidance for export or local market entry in Malaysia.

• Assistance with import/export permissions, NPRA inspections, and post-approval compliance.

• Continuous updates on NPRA, MOH Malaysia, and WHO regulatory changes to ensure ongoing product compliance.

Research & Development (R&D) Services – Malaysia

Our R&D services support your product development, validation, and quality assurance requirements to meet NPRA standards.

Formulation Development

• Development of tablets, capsules, syrups, powders, and injectables.

• Optimization for stability, bioavailability, and efficacy to meet local conditions.

Analytical R&D Services

• Assay, dissolution, impurity profiling, and stability testing.

• Quality control method development and routine analytical testing.

Product Development Reports (PDRs)

• Preparation of comprehensive PDRs for regulatory submission.

• Inclusion of manufacturing process, QC methods, and stability data in line with NPRA requirements.

Clinical Trial & Toxicology Support

• Preparation of clinical trial protocols and final study reports.

• Toxicological evaluation following OECD and NPRA guidelines.

Why Choose Us for the Malaysia Market

• Experienced Team – Experts in NPRA, MOH Malaysia, WHO, and ICH regulatory frameworks.

• End-to-End Support – From formulation development to market registration and compliance.

• Global Exposure – Proven expertise in ROW, ASEAN, US, and EU regulatory environments.

• Timely Submissions – Streamlined processes for faster approvals.

• Custom Solutions – Tailored strategies for your product type, market segment, and regulatory pathway.

Regulatory & Dossier Documentation

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Bioequivalence & Analytical Studies

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Technology Transfer & Safety

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Top Pharma & Regulatory Hashtags – Malaysia

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