Regulatory And Research Services for Bangladesh
Regulatory and Research Services for Bangladesh – Pragya Dossier-DMF Services (PDDS India) & Zoesoe Exports Pvt Ltd
We, at Pragya Dossier-DMF Services (PDDS India) and 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 Bangladesh market. Our services are designed to ensure full compliance with Bangladesh’s National Drug Policy, DGDA regulations, and international standards.
1. Regulatory Services for Bangladesh
We assist companies at every stage of regulatory submission and product approval in Bangladesh, ensuring a smooth market entry:
Product Registration Services
Preparation and submission of drug registration dossiers for prescription and OTC products.
Herbal, Ayurveda, Nutraceutical, Veterinary, and Cosmetic product registrations.
Guidance on local labeling requirements and product information leaflets.
Drug Master File (DMF) Services
Compilation of CTD/ACTD-compliant DMFs for APIs intended for Bangladesh registration.
Support in API regulatory documentation including quality, safety, and stability data.
Bioequivalence (BE) Study Support
Design and coordination of bioequivalence studies in DGDA-approved CROs.
Full BE report preparation in accordance with WHO and Bangladesh regulatory guidelines.
Analytical Method Validation (AMV) Services
Validation of analytical methods as per ICH guidelines.
Documentation for regulatory submission and routine QC support.
Regulatory Consultancy and Compliance
End-to-end regulatory guidance for export or local market entry.
Assistance with import/export permissions, DGDA inspections, and post-approval compliance.
Continuous updates on regulatory changes in Bangladesh to keep your products compliant.
2. Research & Development Services
Our research services support your product development and quality assurance requirements to meet Bangladesh standards:
Formulation Development
Development of tablets, capsules, syrups, powders, and injectables.
Optimization of formulations for stability, bioavailability, and efficacy.
Analytical R&D Services
Assay, dissolution, impurity profiling, and stability testing.
Quality control method development and routine testing.
Product Development Reports (PDRs)
Comprehensive product development dossiers for regulatory submission.
Inclusion of manufacturing process, QC methods, and stability data.
Clinical Trial & Toxicology Support
Preparation of clinical trial protocols and reports.
Toxicological evaluation according to OECD and DGDA guidelines.
3. Why Choose Us for Bangladesh Market
Experienced Team – Professionals with deep expertise in DGDA regulations, WHO guidelines, and ICH-compliant documentation.
End-to-End Support – From product development to registration and market compliance.
Global Exposure – Our experience in multiple ROW, ASEAN, US, and EU markets ensures international standards in documentation and study design.
Timely Submission & Approval – Streamlined processes to reduce registration timelines.
Custom Solutions – Services tailored to your product type, market segment, and regulatory 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