Service 02 / 06
Regulatory Consulting
Submissions built to clear DRAP, NBC and institutional review the first time.
Overview
Regulatory timelines are where Pakistani studies most often slip. Our team prepares, submits and defends clinical trial applications to the Drug Regulatory Authority of Pakistan and the National Bioethics Committee, and manages institutional IRB/EC approvals in parallel rather than in sequence.
- DRAP clinical trial application dossiers
- National Bioethics Committee and IRB/EC submissions
- Import authorisation and IMP release support
Capabilities
What this covers.
Each capability can be contracted on its own or as part of the full service line.
- 01
Regulatory Strategy
Early-stage advice on the pathway for your product in Pakistan — study classification, expected review timelines, precedent from comparable approvals, and the gaps most likely to trigger a query.
- 02
Clinical Trial Application Dossiers
Compilation and quality review of the full DRAP submission package, including protocol, investigator brochure, IMP documentation and site-level annexes.
- 03
Ethics Committee Submissions
National Bioethics Committee submissions alongside institutional IRB/EC packages, with informed consent documents drafted for both English and Urdu comprehension levels.
- 04
Query Response & Defence
Rapid, evidence-backed responses to regulator and ethics queries, including in-person defence of the application where the committee requires it.
- 05
Import & IMP Logistics Authorisation
No-objection certificates, import authorisations and customs documentation for investigational medicinal product and trial supplies.
- 06
Amendments & Annual Reporting
Protocol amendments, safety report submissions, annual progress reports and end-of-trial notifications kept current throughout the study.
Deliverables
What you receive.
Concrete artefacts on an agreed schedule — so progress is verifiable rather than asserted.
- Regulatory strategy memorandum
- Complete DRAP clinical trial application dossier
- NBC and IRB/EC submission packages
- Bilingual informed consent documents
- Query response documentation and approval letters
- Import authorisation and NOC documentation
Related services
Often engaged alongside this.
Next step
Scope a regulatory consulting engagement.
Share your protocol synopsis and target timeline. We come back with scope, assumptions and an indicative budget.