Regulatory approvals for pharmaceutical drugs, cosmetics, and medical devices under CDSCO / DCGI. We manage the complete licensing journey β from product classification to final approval.
Our CDSCO specialists handle technical dossier preparation, Sugam portal filing, query response management, and liaison with the Drug Controller β so you can focus on bringing your products to market.
Comprehensive regulatory services for drugs, cosmetics, and medical devices in India.
Manufacturing or import license for pharmaceutical drugs and formulations under Drugs & Cosmetics Act.
Import or manufacturing license for cosmetic products sold in India under CDSCO regulations.
Registration for medical devices including Class A, B, C & D devices under MDR 2017.
Import license for drugs, cosmetics and medical devices under Form 10 / Form 8 procedures.
Approval from Drug Controller General of India for new drugs, biologicals and clinical trials.
CDSCO approval for conducting clinical trials in India for new drugs and medical devices.
We classify your drug/device/cosmetic under the appropriate CDSCO category and identify the correct application type.
Preparation of complete technical dossier as per CDSCO requirements β CTD format for drugs.
Complete application filed on the Sugam portal (CDSCO) or physically with the licensing authority.
CDSCO may raise technical queries. We prepare detailed, accurate responses to avoid delays.
CDSCO issues the drug/device license or registration certificate upon successful review.
Our regulatory experts will guide you through every step of the CDSCO approval process.
Free consultation. Transparent pricing. Error-free dossiers.