Drug Registration Support

Navigating the regulatory landscape in India can be complex—especially when it comes to getting a new drug approved.

At DrugRegulatoryAffairs.in, we offer expert assistance to help you register pharmaceutical products efficiently and compliantly with the Central Drugs Standard Control Organization (CDSCO) and State Licensing Authorities.

🔍 What We Do

We handle the entire process of drug registration—whether it’s for a new drug, fixed dose combination (FDC), imported medicine, or a generic drug—ensuring that every document, declaration, and dossier meets the stringent requirements of Indian regulations.

🧾 Services Offered

• Form 44 Filing Support
  Guidance on the preparation and submission of Form 44 for new drug applications or fixed dose combinations.
• Form 41 for Import Registration
  Support in preparing documents for the registration of imported drugs or APIs.
• Preparation of Site Master File & Product Master File
  Accurate documentation and formatting for manufacturer and product profiles.
• Liaison with CDSCO & State FDA
  We interact with authorities on your behalf, resolving queries and following up until approval is granted.
• Post-Approval Services
  Support for renewals, changes in manufacturing site, labeling updates, and additional product variations.

🧠 Who Should Use This?

• Indian pharma companies launching new formulations
• API manufacturers registering with CDSCO
• Global firms importing medicines into India
• Contract manufacturers looking for licensing support

📈 Why Choose Us?

• Domain expertise in CDSCO submissions
• Accurate documentation and formatting
• Proven record of successful approvals
• Up-to-date knowledge of Indian regulatory updates