#regulatorysolutions

Submission deadline approaching with an incomplete dossier? Don't let manual research slow you down.

VITALIC RegIntel helps regulatory teams submit faster by: ✔ Instantly identifying dossier gaps. ✔ Finding reliance pathways across 100+ global health authorities. ✔ Using historical authority queries to reduce submission errors and avoid costly rework.

Turn deadline pressure into submission readiness with smarter regulatory intelligence.

🔗 Learn more: https://www.ddregpharma.com/products/vitalic-regintel

Stay ahead of regulations with RE.DOCTOR’s automated compliance tracking. Get real-time alerts for certification periods, authorized visit counts, and mandatory supervisory visits. Our Electronic Visit Verification (EVV) tools and HIPAA-compliant workflows keep your agency audit-ready.

Safety Data Exchange Agreements are operational pharmacovigilance documents that must be treated with the same rigour applied to the submission of a clinical safety data package. A licensing deal that fails to establish a clear, jurisdiction-specific, operationally detailed SDEA does not transfer pharmacovigilance risk, it multiplies it. Regulatory authorities across the EU, US, UK, and Japan have demonstrated repeatedly that they expect MAHs to have documented, functional safety data exchange systems in place. The cost of failure is measured in inspection findings, regulatory action, and, ultimately, patient safety.