Pharmaceutical Regulatory Excellence
Navigating the complex landscape of pharmaceutical regulations in Pakistan requires precision, technical expertise, and deep knowledge of Drug Regulatory Authority of Pakistan (DRAP) protocols. Javid Law Associates provides end-to-end support for new manufacturing units and distribution setups, ensuring your business meets all legal benchmarks.
Regulatory Framework
Our firm manages the interaction between your corporate structure and relevant health authorities. Beyond SECP company registration, we facilitate site verification, Good Manufacturing Practice (GMP) compliance, and product registration dossiers.
| Regulatory Phase | Key Objective |
|---|---|
| Pre-Licensing | Site inspection and facility validation |
| Licensing | Securing Drug Manufacturing License (DML) |
| Operational | Product registration and compliance audit |
Why Choose Javid Law Associates
With years of experience in corporate matters, our team understands the nuances of FBR tax compliance, SECP filing requirements, and the stringent standards set by provincial health departments. We streamline your licensing process, allowing you to focus on production and market entry.
- Expert handling of DRAP regulatory filings
- Seamless integration with SECP and FBR registrations
- Professional audit readiness for GMP and ISO standards
- Comprehensive support for Import Export License Pakistan
- Dedicated consultation for corporate governance
Service heading
Expert guidance for DRAP licensing, quality compliance, and statutory registration for pharmaceutical businesses in Pakistan.
Estimated duration
90-120 days
Price
Rs. 250,000
Requirements
- Valid SECP company registration documents
- Detailed premises site plan and architectural blueprints
- Technical staff credentials and qualification certificates
- Equipment procurement documentation and calibration logs
- FBR NTN and Sales Tax registration certificates
- Board resolution authorizing regulatory applications
Key features
- DRAP manufacturing and distribution licensing
- GMP and quality management system advisory
- Product registration and dossier preparation
- Statutory compliance for SECP and FBR
- Regulatory risk management and site audit support
- Liaison with provincial health authorities
- Corporate legal services and tax strategy
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.