Introduction to Pharma Manufacturing Licensing
Javid Law Associates offers comprehensive support for pharmaceutical manufacturing licensing and regulatory compliance in Pakistan. Navigating the stringent requirements of the Drug Regulatory Authority of Pakistan (DRAP) is crucial for establishing and operating a successful pharmaceutical manufacturing facility. Our seasoned consultants provide end-to-end assistance, ensuring your business meets all legal and operational benchmarks, from initial Company registration Pakistan to final license issuance.
Understanding Regulatory Frameworks
The pharmaceutical sector in Pakistan is governed by comprehensive legislation, including the Drugs Act 1976, the DRAP Act 2012, and associated rules. Obtaining a manufacturing license requires strict adherence to Good Manufacturing Practices (GMP) and detailed documentation covering site specifications, quality control, qualified personnel, and robust production processes. We meticulously guide you through every aspect of these complex regulatory frameworks, ensuring full compliance with national standards.
Why Choose Javid Law Associates?
As your trusted partner for corporate legal services Pakistan since 2004, Javid Law Associates is uniquely positioned to assist. We specialize in quick and hassle-free company registration Pakistan, including SECP company registration and obtaining your NTN Registration Pakistan and ST Registration Pakistan, which are foundational for any manufacturing entity. Our dedicated team, operating from our offices in F-10 Markaz Islamabad and Bahawalpur, ensures personalized service and swift navigation of bureaucratic processes, supporting your goal to register your business in 7 working days for the underlying corporate structure.
Our Comprehensive Service Coverage
Our service encompasses the complete preparation and submission of your manufacturing license application, detailed dossier compilation, facility layout review for GMP compliance, expert support during DRAP inspections, and ongoing regulatory advisory. We help you secure all essential approvals, from initial factory establishment to subsequent product registrations, providing seamless corporate matters consultation.
Key Authorities Involved
Our work primarily involves close liaison with the Drug Regulatory Authority of Pakistan (DRAP) for manufacturing licenses and product registrations. Additionally, we ensure compliance with the Federal Board of Revenue (FBR) for tax matters, including NTN Registration Pakistan and Sales Tax (ST) registration Pakistan, and the Securities and Exchange Commission of Pakistan (SECP) for your legal entity’s company registration in Pakistan. We navigate these authorities efficiently to expedite your licensing process.
Anticipated Timeline & Phases
| Phase | Description | Estimated Time |
|---|---|---|
| I. Company Setup & Basic Registrations | SECP, NTN, ST registrations, initial legal entity setup. | 2-3 Weeks |
| II. DRAP Application & Dossier Preparation | Drafting and compiling detailed manufacturing license application and supporting documents. | 4-6 Weeks |
| III. Facility Inspection & Compliance | Facilitating DRAP site inspection, addressing observations, and ensuring GMP. | 6-8 Weeks |
| IV. Final Approval & License Issuance | Follow-up with DRAP for final license approval. | 2-3 Weeks |
Please note, these timelines are estimates and can vary based on the completeness of documentation and DRAP's processing queue.
Service heading
Expert support for DRAP licensing, regulatory approvals, and ongoing compliance for pharmaceutical manufacturers in Pakistan.
Estimated duration
12-16 weeks (initial licensing)
Pricing
Base price
PKR 350,000.00
Discount
PKR 0.00
Requirements
- SECP-registered Private Limited Company or AOP (Memorandum & Articles of Association)
- National Tax Number (NTN) & Sales Tax (ST) Registration Certificates
- Detailed Proposed Site Plan & Facility Layout (compliant with GMP)
- Particulars of Qualified Technical Staff (Pharmacist, Chemist, Microbiologist)
- Specifications of Quality Control Laboratory setup & Equipment List
- List of Pharmaceutical Products intended for Manufacturing
- Proof of Land/Building Ownership or Lease Agreement
Key features
- Comprehensive DRAP Manufacturing License Application
- Good Manufacturing Practices (GMP) Compliance Advisory
- Detailed Dossier & Documentation Preparation
- Facilitation & Support during DRAP Inspections
- Post-Licensing Regulatory Compliance & Amendments
- SECP, NTN, FBR, and PRA Integration for Manufacturing Entity
About the Author
Written by the expert legal team at Javid Law Associates. Our team specializes in corporate law, tax compliance, and business registration services across Pakistan.