CDSCO Registration Services
The Central Drugs Standard Control Organization (CDSCO) is India’s national regulatory body for pharmaceuticals, medical devices, cosmetics, and diagnostics. As India’s leading CDSCO registration consultant, ACPL provides end-to-end support covering the full product lifecycle — from initial classification and documentation through approval, import licensing, and ongoing compliance.
Whether you are a multinational corporation entering the Indian market or a domestic manufacturer seeking new product approvals, our team has the expertise to navigate CDSCO’s evolving regulatory requirements efficiently and accurately.
What We Handle
- New drug registration and import licenses
- Medical device registration (Class A, B, C, and D)
- Cosmetic product registration and import permits
- IVD product approvals
- Manufacturing license applications
- Product classification and regulatory pathway strategy
- Clinical trial and bioequivalence study approvals
- Post-approval variations and renewals
Our CDSCO Registration Process
Our streamlined approach to CDSCO registration follows a proven methodology developed over 25+ years:
- Product Assessment — We evaluate your product, determine the correct classification, and identify the optimal regulatory pathway.
- Documentation Preparation — Our team prepares the complete CTD/eCTD dossier, including all technical, clinical, and quality documents required by CDSCO.
- Application Submission — We submit your application through the SUGAM portal and manage all correspondence with CDSCO.
- Query Management — We handle any queries or additional information requests from CDSCO reviewers promptly.
- Approval & Licensing — Once approved, we assist with obtaining the import license and ensuring all post-approval requirements are met.
Why Choose ACPL for CDSCO Registration
With 25+ years of experience navigating CDSCO processes, our team understands the nuances of each product category. We maintain active relationships with regulatory authorities and stay ahead of evolving requirements — so your submissions are right the first time.
Our Track Record
We have successfully obtained CDSCO approvals for over 500 products across drugs, medical devices, cosmetics, and diagnostics for clients ranging from multinational corporations to emerging startups entering the Indian market.
Related Services
CDSCO registration often involves coordination with other regulatory processes. Explore our related services:
- Pharmacovigilance — Post-market drug safety monitoring required after CDSCO approval
- Clinical Trials — DCGI approvals for Phase I–IV clinical studies in India
- Materiovigilance — Medical device post-market surveillance
- India Entry Strategy — Complete market entry support for international companies