Regulatory Affairs Service Provider in India
India is one of the world’s fastest-growing life sciences markets, but entering it successfully requires a deep understanding of its unique regulatory ecosystem. At DDReg, we provide specialized regulatory affairs services in India, helping global and local pharmaceutical, biotech, and medical device companies seeking market entry, expansion, or lifecycle support in the region.
With a dedicated team of regulatory professionals, DDReg serves as a trusted pharma regulatory consultant in India, offering strategic guidance and operational support for every stage of your product’s regulatory lifecycle.
Understanding the CDSCO Regulatory Framework
The Central Drugs Standard Control Organization (CDSCO) is India’s national regulatory authority for pharmaceuticals and medical devices, functioning under the Directorate General of Health Services, Ministry of Health and Family Welfare. CDSCO is responsible for:
- Approval of new drugs and clinical trials
- Regulation of import and manufacture of drugs and devices
- Oversight of bioequivalence studies, pharmacovigilance, and labeling compliance
- Granting licenses in collaboration with State Drug Control Organizations
As experienced CDSCO regulatory consultants in India, DDReg works directly with both the central authority and state-level agencies to streamline your approval process, reduce turnaround times, and ensure full adherence with evolving guidelines.
Our Regulatory Expertise in India
DDReg offers end-to-end regulatory affairs consulting to companies seeking product approval and market access in India. Our services are customized to meet the requirements of both global and domestic clients, ensuring that your regulatory processes are aligned with evolving CDSCO, FSSAI, and other national regulatory frameworks.
Our Regulatory Affairs Consulting Services Offer the Following Capabilities:
- Regulatory strategy and pathway assessment
- Product classification and compliance mapping
- Pre-submission consultation and planning
- Preparation, publishing, and submission of dossiers (CTD/eCTD formats)
- Import and manufacturing license support
- Authorized local agent and in-country representative services
- Coordination with CDSCO, FSSAI, BIS, and State Licensing Authorities
- Gap analysis of documentation and regulatory remediation planning
- Lifecycle management (renewals, post-approval changes, labeling updates)
- Support with online portal filings ( SUGAM, FSSAI FLRS, BIS, etc.)
- Regulatory liaison and query handling with Indian authorities
- Import permit and sample import license application support
- Compliance with post-market obligations, reporting, and surveillance
- Local regulatory intelligence and monitoring of policy changes
What Sets DDReg Apart?
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India-Focused Regulatory Expertise
Our team combines scientific acumen with regulatory intelligence to ensure full alignment with Indian and international standards. -
Local Presence, Global Perspective
We serve as an extension of your regulatory team, offering scalable solutions whether you're based in India or operating from overseas. -
Strategic Partner for Market Access
DDReg is not just a regulatory services provider in India, but a long-term partner invested in your commercial success.
Start Your Regulatory Journey with DDReg
Whether you're navigating the drug registration process in India, planning a clinical trial, registering a new medical device, or expanding to Indian market, our experts are here to guide you through every regulatory checkpoint. Contact our team of expert CDSCO regulatory consultants in India to learn how DDReg can accelerate your journey to market.
