India's pharmaceutical regulatory framework is governed by the Drugs and Cosmetics Act and administered by the Central Drugs Standard Control Organisation (CDSCO). RBridge Lifesciences provides comprehensive support for domestic drug registration, dossier preparation, and GMP compliance upgradation.
What We Offer
- Gap Assessment and End-to-End Preparation of Dossier
- Agency Liaisoning and Inspection Management
- GMP Compliance, Upgradation, and Renewal
- CDSCO / DCGI Zonal and Central Office Liaisoning
- New Drug Applications and Generic Drug Submissions
India Regulatory Landscape
- CDSCO is the central regulatory authority; State Licensing Authorities manage manufacturing licences
- New Drug and Clinical Trials Rules 2019 govern submissions for new drugs and clinical trials
- Schedule M under the Drugs and Cosmetics Act governs GMP requirements
- India is a signatory to various international pharmacopoeial conventions and is a PIC/S observer