Schedule: Monday - Friday - 9:00 - 05:00
+92-51-2253641

Service

Drug Regulatory Affairs Services

We offer our Services for:

  • Drug Regulatory Authority of Pakistan
  • Federal Board of Revenue
  • Ministry of Commerce
  • Ministry of Narcotics Control
  • National Control Laboratory for Biological
  • Ministry of National Health Services Regulation and Coordination

Drug Regulatory Authority of Pakistan

Pharmaceutical Industries

  • NOC Approval/ Site Approval to establish drug manufacturing unit
  • Preparation & Approval of Layout Plan
  • Grant of Drug Manufacturing License
  • Registration of Imported products
  • Registration of Local Products
  • Registration of Export Products
  • Registration of products for Contract /Toll manufacturing/ Third Party Manufacturing
  • Preparation of Files (Dossiers)
  • Transfer of Registration
  • Price Fixation of products, re-fixation and hardship cases of pharmaceutical products
  • Approvals of quota for controlled substance
  • Submissions of Pharmacovigilance Reports
  • Approvals for clinical trials, B.A & B.E. Studies

Health and OTC

  • Grant of Enlistment Certificate to Manufacturer/Importer
  • Enlistment of Products (Local/Import)
  • Grant of GMP Certificate
  • Enlistment of Contract Givers

Medical Devices

  • Grant of Establishment License to Manufacture Medical Devices
  • Grant of Establishment License to Import Medical Devices
  • Enlistment & Registration of Medical Devices for Local Manufacturing
  • Enlistment & Registration of Medical Devices for Import
  • Provisional Establishment License to Import Medical Devices Mentioned In Schedule D
  • Provisional Registration of Medical Devices in Schedule-D
  • Export permit of Medical Devices

Ministry of Narcotics Control

  • Quota Approvals for narcotic substances
  • Allocation of Quota
  • Consumption Report

National Control Laboratory for Biological

  • Issuance of Lot Release Certificate for biological drugs

Federal Board of Revenue

  • Taxation Process
  • Duties and other tax relation matters

Ministry of Commerce

  • Assistance regarding Import-Export Policy
  • Exemption of Duties related matters