Regulatory Affairs & Compliance

Expert pharmaceutical regulatory services in Pakistan. We specialize in DRAP registration, CTD dossier preparation, cGMP compliance, and pharmacovigilance.

Regulatory Affairs & Compliance

Navigating the complex landscape of pharmaceutical regulations with precision and integrity. At Air Pharma, we ensure every product meets the stringent requirements of the Drug Regulatory Authority of Pakistan (DRAP) and international health standards.


Ensuring Market Authorization & Safety

Our Regulatory Affairs (RA) team acts as the vital link between our scientific development and the regulatory bodies. We manage the entire product lifecycle—from initial registration to post-market surveillance.

 

Dossier Preparation (CTD/eCTD)

Expertise in compiling Common Technical Documents (CTD) for new drug applications, ensuring technical data, clinical summaries, and quality modules are perfectly aligned for rapid approval.

 

cGMP & Licensing

Maintaining our Drug Manufacturing License (DML) through rigorous adherence to Current Good Manufacturing Practices. We handle site inspections, renewals, and facility upgrades documentation.

 

Pharmacovigilance & Post-Market Surveillance

Continuous monitoring of product safety. We maintain a robust system for reporting adverse drug reactions (ADRs) and managing product variations or renewals.

Key Regulatory Strengths

  • DRAP Liaison: Direct and transparent communication with regulatory authorities.
  • Labeling & Packaging: Ensuring 100% compliance with Drug Labeling and Packing Rules.
  • International Standards: Alignment with WHO and ICH guidelines for future export readiness.
  • Intellectual Property: Ethical management of patents and trademark registrations.

"Our regulatory precision is your guarantee of patient safety."

The Path to Compliance

From initial formulation to final market authorization, Air Pharma manages every detail to ensure zero compliance gaps.

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