Drug Regulatory Services for Manufacturers
BlackBows supports pharmaceutical manufacturers in developing strong regulatory strategies and preparing precise, compliant dossiers for drug approvals in India.
Our team provides end-to-end assistance—from application filing to regulatory representation—ensuring smooth approvals and minimal delays. We also represent clients in SEC meetings and provide continuous guidance throughout the approval lifecycle.
Core Regulatory Services
- Investigational New Drug (IND)
- New Drug Approval (NDA)
- Subsequent New Drug Approval (SND)
- BE NOC for Export
- Special / Neutral Code for Export
- SEC Meeting Representation
- Toxicity & BE Studies
- Clinical Trials
- Medical Writing
CDSCO Regulatory Framework
Central CDSCO
- IND, NDA & SND Approvals
- BE NOC for Export
- SEC Meetings
- Clinical Trials & Studies
Zonal CDSCO
- Test License
- Export NOC
- Dual NOC
State FDA
- Manufacturing License
- Form 29 for Test Batch
- Wholesale License
- Free Sales Certificate
Manufacturing License
Manufacturing pharmaceutical products in India requires a valid license under the Drugs & Cosmetics Act, 1940. The process involves submission of accurate documentation to the State Licensing Authority (SLA) or Central License Approving Authority (CLAA).
BlackBows ensures a smooth and compliant licensing process through expert guidance and documentation support.
Drug For Importer
We provide comprehensive support across all aspects of drug import regulations—ensuring accurate documentation, efficient approvals, and faster market entry with minimal delays.
Pre – Marketing
To register a drug product in India, appointing an Authorized Agent is mandatory. The agent represents the company for regulatory submissions and compliance.
BlackBows ensures smooth coordination, accurate filings, and faster approvals.
Marketing authorization is granted by CDSCO after evaluation of product quality, safety, and compliance.
BlackBows handles the complete process from documentation to final approval.
Registration of drug products and manufacturing sites is required before import into India.
BlackBows ensures accurate submissions and timely approvals.
A valid import license is required to legally import pharmaceutical products into India.
BlackBows manages the entire licensing process efficiently.
Test licenses are required for importing drug samples for testing and evaluation.
BlackBows ensures quick approvals with proper compliance.
Post-marketing Services
Required for changes in registered products or documentation after approval.
BlackBows ensures smooth post-approval compliance handling.
Timely renewal of registration certificates is essential for continuous market presence.
BlackBows manages re-registration without delays.
Requires submission of stability data and regulatory approval.
BlackBows supports documentation and approvals for lifecycle extension.