Diagnostics
Our Regulatory Affairs team guides products through every stage of global approval — from early strategy to submission, approval, and post‑market lifecycle management.
We prepare and compile eCTD/DMF dossiers (IND, IMPD, NDA, BLA, MAA), manage agency interactions (FDA, EMA, SFDA, MHRA, GHC, MENA, DRAP), and ensure inspection readiness with robust documentation and data integrity.
Comprehensive Regulatory Services
End‑to‑end support for regulatory pathways across small molecules, biologics, and devices, covering strategy, submission, and lifecycle change control.
- Regulatory strategy and gap/risk assessment for target markets.
- eCTD/DMF authoring, compilation, and publishing for IND, IMPD, NDA, BLA, MAA.
- Agency liaison and meeting coordination (FDA/EMA/SFDA/MENA/MHRA/GHC/DRAP).
- Labeling, variations, renewals, and post‑approval change management.
- Clinical/CMC documentation alignment and data integrity controls.
- Inspection readiness audits and mock interviews.
- Regulatory intelligence and lifecycle maintenance planning.
eCTD/DMF Compilation & Publishing
Structure, validate, and publish electronic dossiers with correct granularity, cross‑references, and lifecycle sequences.
Agency Strategy & Meetings
Plan Type B/C meetings, briefing packages, and minutes — aligning expectations to reduce review cycles.
Lifecycle & Labeling Management
Handle variations, renewals, safety updates, and labeling changes with full change-control documentation.
Our Approach
Align regulatory strategy with clinical and CMC plans early, apply risk‑based review of evidence, and maintain audit‑ready documentation.
- Proactive engagement with authorities to clarify expectations.
- ICH, GxP, and data integrity (ALCOA+) built into every submission.
Inspection Readiness
Mock audits, document reviews, and team training to prepare for regulatory inspections.
Proactive Approach
Early CMC and clinical plan, clear engagement with authorities.
Global Regulatory Network
We collaborate with experienced publishers, translators, and regional agents to streamline submissions and lifecycle changes across markets.
Dossier Development
Author, QC, and publish modules 1–5 with consistent granularity and hyperlinks.
Agency Engagement
Plan meetings, submit responses, and track commitments with an auditable history.
Post‑Approval Support
Manage renewals, PV updates, and market‑specific labeling with change control.
Frequently asked questions about Regulatory Affairs
Strategy, eCTD authoring/publishing, agency meetings, labeling, variations/renewals, inspection readiness, and lifecycle maintenance.
We prepare and compile eCTD/DMF dossiers (IND, IMPD, NDA, BLA, MAA), manage agency interactions (FDA, EMA, SFDA, MENA, MHRA, GHC, DRAP), and ensure inspection readiness with robust documentation and data integrity.
We coordinate with FDA, EMA, SFDA, MENA, MHRA, GHC and DRAP
Through QMS implementation, vendor audits, CAPA tracking, change control, and continuous monitoring aligned with ICH Q10 and Annex 15.
Yes. We shortlist, contract, and manage CMO/CDMOs/CROs with KPI tracking, risk registers, and clear governance for timelines and quality.