Regulatory And Research Services for Cambodia

Regulatory and Research Services for Cambodia – Pragya Dossier-DMF Services (PDDS India) & Zoesoe Exports Pvt Ltd

We, at Pragya Dossier-DMF Services (PDDS India) and Zoesoe Exports Pvt Ltd, provide specialized regulatory and research support for pharmaceutical, herbal, nutraceutical, veterinary, and cosmetic products targeting the Cambodian market. Our services are designed to meet the requirements of the Ministry of Health (MoH) Cambodia, the Department of Drugs and Food (DDF), and international regulatory standards (WHO, ICH, ASEAN guidelines).

1. Regulatory Services for Cambodia

We help companies achieve smooth and compliant product registrations in Cambodia:

• Product Registration Services

  • Preparation and submission of registration dossiers for pharmaceuticals, nutraceuticals, herbal, veterinary, and cosmetic products.

  • Compliance with ASEAN Common Technical Dossier (ACTD) format and MoH Cambodia requirements.

  • Guidance on local labeling, artwork, and packaging regulations.

• Drug Master File (DMF) Services

  • Preparation of CTD/ACTD-compliant DMFs for APIs.

  • Inclusion of quality, safety, and stability documentation for regulatory submission.

• Bioequivalence (BE) Study Support

  • Design and coordination of BE studies as per WHO and ASEAN guidelines.

  • Preparation of complete BE reports for submission to Cambodian regulators.

• Analytical Method Validation (AMV) Services

  • Method validation in line with ICH Q2(R1) guidelines.

  • Complete documentation for regulatory submission and QC support.

• Regulatory Consultancy & Compliance

  • Import/export license support and market authorization assistance.

  • Ongoing regulatory compliance updates to ensure smooth approvals.

2. Research & Development Services

Our research services help ensure quality, safety, and efficacy of products for Cambodia:

• Formulation Development

  • Expertise in tablets, capsules, syrups, powders, topical and injectable dosage forms.

  • Formulation optimization for stability and bioavailability.

• Analytical R&D Services

  • Development and validation of QC methods, impurity profiling, assay, dissolution, and stability studies.

• Product Development Reports (PDRs)

  • Complete reports covering manufacturing process, formulation development, QC methods, and stability studies for submission.

• Clinical Trial & Toxicology Support

  • Toxicological studies and clinical trial documentation as per OECD and MoH Cambodia standards.

3. Why Choose Us for Cambodia Market

• Regional Expertise – Experienced in ASEAN guidelines and Cambodian MoH requirements.

• Comprehensive Services – Covering dossier, DMF, BE studies, AMV, and R&D support.

• Time-Efficient Solutions – Streamlined processes for faster approvals.

• Tailored Approach – Custom support for your product type and business strategy.

4. Contact Us

Pragya Dossier-DMF Services (PDDS India)
Email: info@pdds.in
Website: www.pdds.in

Zoesoe Exports Pvt Ltd
Email: info@zoesoe.com