What We Do
Commitment to Innovation
Welcome to D.K. Pharm Regulatory Service
D.K. Pharm Regulatory Service is a trusted name in providing expert regulatory support for pharmaceutical product registration across emerging international markets. Since our establishment in 2023, we have successfully helped numerous clients get their products registered smoothly and start commercial operations without delay.
Why Choose Us?
Deep understanding of country-specific regulatory requirements
Proven track record with successful product registrations
Trusted by clients worldwide for timely and professional service
Dedicated to helping our clients launch their products with confidence
Let us be your reliable partner for pharmaceutical regulatory services and ensure your success in global markets.
Our Services Include:
- 1. Dossier Preparation (CTD/ACTD / country specific formats)
- 2. Query Response & Resolution
- 3. DMF (Open Part Only)
- 4. Analytical Method Validation (AMV)
- Assay
- 5. Dissolution
- 6. Related Substance Studies
- CDP
- 7. BE (Bioequivalence)
- 8. BTIF Preparation
We Offer
Technical Document Support In:
ROW Markets Only, including but not limited to:Ghana, Nigeria, Myanmar, Philippines, Vietnam, Uganda, Tanzania, Congo, Ivory Coast, Costa Rica, Cambodia, Cameroon, Togo, Nepal, Bhutan, Uzbekistan, Tajikistan, Armenia, peru, panam and Azerbaijan .
Our technical documentation and regulatory support ensure that our clients’ pharmaceutical products meet the necessary requirements, leading to faster approvals and easier market entry.
Our Clients
We are proud to work with pharma companies across the globe.
Our clients trust us for accurate documentation, on-time delivery, and transparent communication. We've supported product registrations in various markets including:
Ghana
Nigeria
Myanmar
Philippines
Vietnam
Uganda
Tanzania
Congo
Ivory Coast
Costa Rica
Cambodia
Cameroon
Togo
Nepal
Bhutan
Uzbekistan
Tajikistan
Armenia
Azerbaijan
Peru