From regulatory strategy to CDSCO approval — our RA experts handle every step of your drug or medical device registration.
We cover all CDSCO licenses and registrations under the Drugs & Cosmetics Act and Medical Devices Rules, 2017.
CDSCO approval for pharmaceutical drug manufacturing including allopathic, Ayurvedic, homeopathic, and biological drugs. Includes GMP compliance and site inspection coordination.
CDSCO import license for bringing pharmaceutical drugs, raw materials, and Active Pharmaceutical Ingredients (APIs) into India. Required for customs clearance and market authorization.
Registration of medical devices under Medical Devices Rules 2017. Class A/B devices on SUGAM portal, Class C/D require clinical evaluation. Covers diagnostics, implants, equipment.
CDSCO approval to conduct clinical trials for new drugs, biologicals, and medical devices in India. Includes Ethics Committee approval, CTRI registration, and CDSCO CTA application.
CDSCO license for manufacturing or importing cosmetics in India under Schedule S of the D&C Act. Required for all cosmetic products including skin care, hair care, and color cosmetics.
CDSCO registration for diagnostic kits, reagents, test strips, and laboratory equipment used in clinical diagnosis. Includes COVID test kits, blood glucose meters, pregnancy tests.
CDSCO and State Drug Controllers enforce strict action against unlicensed pharmaceutical and medical device operations.
India's leading regulatory affairs consultancy for pharma and medical devices with 3,000+ licenses and expert RA team.
Legally manufacture or import drugs and medical devices for the Indian market with valid CDSCO approval and state drug license.
Experienced regulatory affairs professionals with deep knowledge of CDSCO, SUGAM portal, and CTD dossier requirements.
CDSCO license enables WHO-GMP certification and Certificate of Pharmaceutical Products (CoPP) for global drug export.
CDSCO licensed manufacturers eligible for government hospital tenders, Jan Aushadhi scheme, and public health supply.
CDSCO approval signals product safety, efficacy, and quality — critical for building trust with healthcare professionals and patients.
Expert dossier compilation minimizes CDSCO queries and accelerates approval timelines for drugs and medical devices.
Our regulatory affairs team manages the complete CDSCO application from regulatory strategy to license issuance.
Identify product classification, applicable regulations, license type, required data, and regulatory pathway for fastest approval.
Prepare complete regulatory dossier including administrative, technical, quality, safety, and efficacy data in CDSCO-required format.
Submit application on SUGAM CDSCO portal with complete dossier and government fee. Receive application tracking number.
CDSCO officer reviews application. We prepare and submit timely responses to technical queries and additional data requests.
For manufacturing licenses, CDSCO/State Drug Inspector conducts GMP inspection. We prepare your facility and documentation.
Receive CDSCO license certificate / registration number. Begin manufacturing, import, or sale with full regulatory authorization.
Our RA team compiles and reviews all documents for a complete, query-free CDSCO application.
Any business manufacturing, importing, or selling drugs, medical devices, or cosmetics in India requires CDSCO approval.
Get answers to CDSCO regulatory questions from our expert pharmaceutical regulatory affairs team.
Real results from pharma and medical device companies that trusted Corpbiz for CDSCO compliance.
Join 3,000+ pharma & device companies that trusted Corpbiz for CDSCO licensing. Expert RA team, complete dossier support, fastest approvals.
