GeneDriftOS brings regulatory strategy, pharmacovigilance case flow, and multi-market compliance into a single command layer. Built for consultancies that move drugs from development to market across continents.
Every dossier, every safety case, every market deadline in one place. No more chasing updates across email threads and shared drives.
CTD, ACTD, and regional format submissions tracked end-to-end. Know exactly where every dossier stands across every market you operate in.
Adverse event intake through final submission. Automated triage, SLA monitoring, and compliance tracking for your entire pharmacovigilance operation.
Real-time monitoring of guideline changes across FDA, EMA, CDSCO, and regional authorities. Know before your clients ask.
QMS oversight, CAPA tracking, audit trail generation, and artwork compliance. The operational backbone that keeps everything in standard.
Three layers of operational intelligence that compound over time.
Every client project, regulatory submission, PV case, and compliance milestone flows into one system. No more fragmented tracking across tools.
AI-assisted case triage, document assembly, and regulatory change alerts. Your team focuses on strategy while the system handles throughput.
Take on more clients, more markets, more submissions without linearly scaling your team. Operational leverage through intelligent automation.
Regulatory consulting has always been about deep domain knowledge. GeneDriftOS adds the operational layer that lets that knowledge compound, crossing borders and time zones without bottlenecks.