Two hundred successful DRAP approvals, zero shortcuts. Our regulatory specialists manage every step of pharmaceutical, biological, medical device and IVD registration in Pakistan from first dossier to final licence.
Request a Regulatory Assessment →We handle all classes of DRAP registration. Pharmaceuticals, biologicals, medical devices and IVDs. Using CTD and eCTD formats that meet DRAP's latest digital submission requirements.
Our team has successfully navigated every type of variation, renewal, pricing revision and import clearance Pakistan requires.
Start Your Filing →Full Common Technical Document compilation and electronic submission via DRAP's eAPP portal correctly formatted first time.
New product registrations for pharmaceuticals, biologicals, medical devices and IVD diagnostics across all schedules and categories.
Price revision applications, post-approval changes, line extensions and formula variations managed end to end.
Import permits, NOCs, Drug Sales Licence maintenance and Establishment Licence compliance keeping your supply chain moving.
Proactive renewal tracking so registrations never lapse with full variation and reporting management throughout the product lifecycle.
Coordination of DRAP GMP inspections for foreign manufacturers including site visits to China and Ukraine previously conducted by our team.
We review your product dossier, classification, existing data and current DRAP status to design the right regulatory pathway.
CTD/eCTD compilation, gap analysis, missing-data resolution and formatting to DRAP's exact technical requirements.
eAPP portal submission with complete accompanying documentation, fees and track-and-trace of all correspondence.
Rapid professional responses to DRAP queries, deficiency letters and clarification requests — minimising back-and-forth delays.
Licence issuance management, pricing approval coordination and import permit activation — ready for market entry.
Renewal calendar management, variation tracking, pharmacovigilance support and annual reporting to keep registrations active.
Every dossier we submit meets DRAP's current standards — no incomplete data, no deferred questions, no shortcuts that come back to haunt you at renewal.
Send us your product details and we will return a regulatory assessment within 48 hours — no obligation.