40% faster PV cycle time
Accelerate adverse-event intake, coding, routing, and clock management.
Pharmaceuticals
Run safety, regulatory, quality, medical, and commercial operations on one controlled AI layer.
Round Infinity brings purpose-built agents to pharmacovigilance, regulatory submissions, medical information, quality, field medical, product complaints, and supply operations, with configured review and audit trails.
Pharmaceutical manufacturersSpecialty and generic pharmaMedical, safety, quality, and regulatory teams
Who feels the difference
Safer, better-served patients
Empowered medical and safety teams
Confident quality and regulatory leaders
Business impact
Measurable gains for Pharmaceuticals.
The operating model focuses on three industry priorities: 40% faster PV cycle time; 33% faster document QC; and 100% decision audit trail.
33% faster document QC
Extract, compare, and review regulated content with traceable controls.
100% decision audit trail
Record every automated action, confidence threshold, and human review.
One connected operating flow
The pharmaceutical operations flow, from regulated signal to reviewed action and submission.
Each stage shows the industry work, what Round Infinity automates, and the horizontal platform capabilities carrying context and control across the process.
1
Capture Safety, Medical & Quality Signals
Adverse events, product complaints, HCP or patient questions, deviations, site events, and regulatory requests enter through any approved channel.
Voice/email AI · Portals · Document intake
2
Extract, Code & Classify
AI identifies patient, reporter, product, event, seriousness, expectedness, quality attributes, jurisdiction, and required function using controlled dictionaries.
Document AI · MedDRA/WHO-DD · Rules
3
Route & Control Regulatory Timelines
Cases move to pharmacovigilance, medical, regulatory, clinical, or quality teams with clock, priority, confidence, and required review.
Workflow orchestration · SLA · Human review
4
Investigate, Author & Approve
Teams coordinate follow-up, assessment, CAPA, dossier content, approved responses, evidence, redaction, review, and sign-off.
Knowledge AI · Document automation · E-sign
5
Submit, Respond & Preserve the Audit Trail
Authority, partner, HCP, patient, and internal responses are delivered, tracked, reconciled, closed, and retained with every decision.
Integrations · Audit trail · Operational intelligence
Horizontal platform capabilities working across every stage
Patient, HCP, and partner portals
Regulated document processing
Controlled medical knowledge
Confidence-based human review
Regulatory timeline orchestration
Audit-ready operations dashboards
Industry AI agents & accelerators
Purpose-built agents, engines, and copilots for pharmaceuticals.
These are configured for the industry task, not generic chatbots. Each works inside permissions, confidence thresholds, human-review rules, and one audit trail.
Pharmacovigilance AI Agent
Captures adverse events, applies MedDRA/WHO-DD coding, and tracks expedited reporting timelines.
Clinical Trial Operations AI Agent
Monitors site milestones, deviations, queries, and participant-support actions.
Regulatory Submission AI Agent
Assembles dossier content, tracks authority correspondence, and flags at-risk milestones.
Medical Information AI Assistant
Answers approved-label questions and routes safety or off-label inquiries for expert review.
Quality & CAPA AI Agent
Classifies deviations, coordinates investigation, and tracks corrective and preventive action.
Field Medical AI Accelerator
Summarizes KOL interactions and structures insights for medical science liaisons.
Product Complaint AI Agent
Captures product evidence and coordinates quality, safety, replacement, and customer response.
Pharma Supply Exception AI Agent
Tracks cold-chain, shortage, partner, release, and delivery exceptions through resolution.
See Pharmaceuticals operations running end to end.
We’ll map one priority workflow to your systems, controls, channels, and teams, and show how Round Infinity completes the work.
Book a focused walkthrough