Strategic Regulatory Support for India’s Pharmaceutical Market
India's pharmaceutical sector is not only one of the largest globally, it’s also one of the most closely regulated. For both domestic manufacturers and international stakeholders, securing regulatory approvals under India's Central Drugs Standard Control Organization ( CDSCO) demands deep expertise, process transparency, and continuous engagement with evolving guidelines.
At DDReg, we bring a focused, hands-on approach to supporting Pharmaceutical Product Registration in India from drug development to post-marketing compliance strategies for organizations entering or expanding within the Indian market.
Our Pharmaceutical Product Regulatory Services in India
We provide comprehensive regulatory support for manufacturers, marketers, importers, and distributors. Our service suite includes:
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Pharmaceutical Product Registration in India
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Import and India Drug License Registration
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CDSCO Pharmaceutical Products Manufacturing License
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Dossier & eCTD Services
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Regulatory Strategy & Intelligence
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Lifecycle Management & Post-Approval Services
Why do you need Regulatory Expertise for Pharmaceutical Product in India
India's regulatory ecosystem, governed primarily by the CDSCO under the Ministry of Health and Family Welfare, is multifaceted. Whether it's Drug Registration in India for New Drugs , New Biologicals, generics, biosimilars , or APIs, or obtaining an import license or manufacturing license for pharmaceutical products, every step must align with exacting documentation standards, clinical data requirements, and site inspection protocols.
Our clients often face challenges such as:
- Understanding various CT forms including 01, 04, 04A, 05, 08, 10, 12, 13, 16, 18, 21 & so on and the related procedures
- Sourcing reliable updates on state-specific regulatory practices
- Addressing queries raised via the SUGAM Portal (CDSCO Registration for Pharmaceutical Products)
- Ensuring dossiers meet the latest Indian CTD or eCTD requirements
With a strong presence across Indian regulatory zones and an in-house team of regulatory scientists, DDReg enables organizations to overcome these bottlenecks and move toward market entry or expansion with clarity.
Dedicated Support for Foreign Manufacturers
Entering India’s regulated market from abroad? DDReg simplifies regulatory access for global pharmaceutical clients looking to register and export products into India.
- End-to-end support via the SUGAM Portal CDSCO Registration for Pharmaceutical Products
- Legalized documentation, Indian agent representation, and site inspections
- Streamlined communication with CDSCO for foreign RC applications
- Local partner liaison for customs, warehousing, and distribution
Whether your goal is Pharmaceutical Products Exports from India or establishing a compliant import operation, we provide scalable regulatory pathways aligned with Indian standards.
Therapeutic & Product Segment Experience
Our team brings regulatory and scientific acumen across a wide range of product classes:
- Prescription Drugs (Rx)
- Over the Counter (OTC) Pharmaceuticals
- Hormonal Preparations
- Specialty Injectables
- Controlled Substances
- Orphan & Critical Care Drugs
- APIs and Bulk Pharmaceuticals
Understanding India’s Drug Registration Pathways
We help companies identify the optimal registration pathway based on product type, clinical status, and urgency:
| Pathway | Description |
|---|---|
| New Drug Approval Pathway | For New Drugs, New Biological agents |
| Standard Pathway | For generics and established drugs (12–18 months) |
| Fast Track or Priority Review | For critical care or unmet need products |
| Biologic Pathway | Involving extensive clinical and CMC review |
| Parallel Import & Manufacturing Licensing | For accelerated local production |
Our team also assists with technology transfers, dossier localization, and bridging studies where required.
Why Choose DDReg?
- 15+ Years of Experience in Indian and global regulatory submissions
- In-house Regulatory Experts across therapeutic areas
- On-ground Coordination with CDSCO, State FDAs, and testing laboratories
- Track Record: 500+ successful approvals and ongoing maintenance projects
- Integrated Post-Approval Support (vigilance, compliance, variations)
When it comes to India Drug License Registration and regulatory project execution, DDReg is a trusted partner for pharmaceutical success.