Regulatory And Research Services for Bhutan

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

We, at Pragya Dossier-DMF Services (PDDS India) and Zoesoe Exports Pvt Ltd, provide comprehensive regulatory and research support for pharmaceutical, herbal, nutraceutical, veterinary, and cosmetic products targeting the Bhutan market. Our services ensure full compliance with Bhutan’s Ministry of Health (MoH) regulations, Drug Regulatory Authority requirements, and international quality standards.

1. Regulatory Services for Bhutan

We assist companies at every stage of regulatory submission and product approval in Bhutan:

• Product Registration Services

  • Preparation and submission of drug registration dossiers (allopathic, herbal, nutraceutical, veterinary, and cosmetic products).

  • Guidance on local labeling requirements, packaging, and product information leaflets.

• Drug Master File (DMF) Services

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

  • Full support for API regulatory documentation, including quality, safety, and stability data.

• Bioequivalence (BE) Study Support

  • Design and coordination of BE studies as per international standards.

  • Preparation of BE reports suitable for submission to Bhutan regulatory authorities.

• Analytical Method Validation (AMV) Services

  • Validation of analytical methods as per ICH guidelines.

  • Documentation for regulatory submission and quality control.

• Regulatory Consultancy & Compliance

  • Guidance for import/export permissions and product registration.

  • Support with compliance inspections and ongoing regulatory updates.

2. Research & Development Services

We provide research services to help ensure product quality and market readiness for Bhutan:

• Formulation Development

  • Tablets, capsules, syrups, powders, injectables – optimized for stability, efficacy, and regulatory compliance.

• Analytical R&D Services

  • Assay, dissolution, impurity profiling, stability testing, and QC method development.

• Product Development Reports (PDRs)

  • Complete documentation of product development, manufacturing process, QC methods, and stability data.

• Clinical Trial & Toxicology Support

  • Preparation of clinical trial protocols and toxicological evaluation reports according to OECD and Bhutan MoH guidelines.

3. Why Choose Us for Bhutan Market

• Expertise – Experienced team familiar with Bhutan regulatory framework and international standards.

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

• Timely Submissions – Optimized process to reduce approval timelines.

• Custom Solutions – Tailored services for your product type and market 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