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Central Drugs Registration in India

Central Drugs Registration in India

Accredited Consultants Pvt. Ltd., Your Regulatory Compliance Partner

The Central Drugs Standard Control Organization (CDSCO) is India’s national regulatory authority that oversees the approval and regulation of drugs, cosmetics, and medical devices. Companies need to obtain Central Drugs Registration through CDSCO to manufacture, import, or market new drugs in India.

At ACPL, we provide expert guidance and support to help pharma companies achieve quick, easy, and compliant drug registrations.

Our Services for Central Drugs Registration

  • New Drug Applications (NDA/NDR): We guide submissions and clinical trial approvals.
  • Import & Manufacturing Licenses: We support both Indian and international companies.
  • Clinical Trial Approvals: We assist with protocol preparation, ethics approvals, and regulatory filings.
  • Formulations & Fixed Dose Combinations (FDCs): We help with applications and approvals.
  • Test Licenses for R&D: We provide documentation for research and clinical evaluation.
  • Post-Market Compliance: We manage renewals, amendments, and pharmacovigilance support.

Why Choose ACPL?

  • With over 25 years of regulatory experience in India.
  • We maintain strong connections with CDSCO and State Licensing Authorities.
  • We have a proven track record of successful registrations for global pharma companies.
  • We ensure compliance from dossier preparation to final approval.

Contact Us

Accredited Consultants Pvt. Ltd. (ACPL)
B-3, Sector-6, Noida, Uttar Pradesh, India
+ 91-9266665201 | + 91-9310040434
acplgroupindia.co.in

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