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New drug & medical registration in india

New Drug and Medical Registration in India

ACPL Company, Your Trusted Regulatory Partner

Bringing a new drug or medical device to the Indian market requires strict compliance with CDSCO guidelines and the Medical Device Rules (MDR), 2017. At ACPL Company, we make this complex process simple, smooth, and efficient.

Our Services

  • New Drug Registration (NDR): Clinical trial approvals, dossier preparation, and CDSCO submissions.
  • Medical Device Registration (MDR): Classification, documentation, testing, and licensing assistance.
  • Regulatory Submissions: Filing of CTD/eCTD, CT-04, CT-21, MD-14, MD-15, and related forms.
  • Clinical Evaluation and Testing: Protocol development, ethics approvals, and post-market surveillance.
  • Import and Manufacturing Licenses: Guidance for both Indian and overseas companies.

Why Choose ACPL?

  • 25+ years of regulatory expertise
  • Strong connections with CDSCO and state authorities
  • Complete compliance support
  • Trusted partner for pharmaceutical and medical device companies worldwide

Official Information

ACPL Company
B-3, Sector-6, Noida – 201301, Uttar Pradesh, India
+91-9266665201 | +91-9310040434

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