Pharmaceuticals
Process every safety case, quality event and regulatory commitment on time, with a full audit trail.
Ten pharma AI agents on one governed layer for pharmacovigilance, quality and CAPA, product complaints, medical information, regulatory submissions, field medical, clinical trial operations, supply exceptions and acquisition integration. Agents prepare the work; qualified people make every regulated decision.
Built for pharmaceutical manufacturers, specialty and generic pharma and safety, medical, quality and regulatory teams.
Works alongside your validated safety database and RIM. Round Infinity runs intake, triage, medical information, complaints and CAPA around them. Validated case records stay in your safety system.
How Pharmaceuticals runs on Round Infinity
Each step shows what the AI agents do, where your team works, the workflow that keeps it controlled and what you track. People approve what matters, and every action is recorded.
Capture safety cases and enquiries from every channel
Enquiries arrive from patients, doctors, partners and field teams. AI answers on-label questions from approved responses and captures anything that might be a safety signal or a complaint.
Extract and code each case automatically
Possible side effects are found in calls, emails, complaints and literature and turned into structured cases. Product complaints are captured with batch and complaint type.
Route every case against its regulatory clock
Every case is routed against its regulatory deadline, so reporting clocks are never missed. Regulatory submissions are checked for missing or expired documents for each market.
Investigate and approve with qualified sign-off
Deviations and investigations are structured and classified, with likely root causes suggested. Qualified people review and approve every decision.
Submit on time with a complete audit trail
Reports are submitted on time with a complete audit trail. After an acquisition, procedures from both companies are compared so differences can be resolved and the integration tracked.
Connects to Safety database (Argus, Vault Safety, ArisGlobal), QMS, LIMS and document management, Regulatory information and trial management and ERP and CRM.
See everything in the pack
Business applications
- Safety Case ManagementEvery case with seriousness, coding status and the regulatory clock for each market.
- Medical Inquiry CenterHCP and patient questions across voice, WhatsApp and email with approved responses and trends.
- Product Complaint HandlingComplaints linked to batch, samples, evidence and investigation.
- Quality Events & CAPADeviations, investigations, CAPA and effectiveness checks across plants.
- Submission TrackerDossiers, variations, renewals, transfers and authority queries, milestone by milestone.
- Supply Exception DeskCold-chain excursions, shortages, release delays and partner delivery issues.
- SOP HarmonisationPaired SOPs from merged organisations, differences, harmonised drafts and training sign-off.
- Synergy TrackerIntegration initiatives, owners, targets and ERP actuals.
- HCP, Patient & Partner PortalsSelf-service for questions, reports, orders, documents and requests.
- Plant Mobile AppDeviations and quality events logged on the shop floor.
- Reviewer WorkspaceMedical, quality and regulatory review with e-signature.
AI agents
- Pharmacovigilance AI AgentFinds any mention of a possible side effect in calls, emails, inquiries, complaints, partner reports and literature, checks the four minimum criteria for a valid case, removes duplicates, codes events (MedDRA) and drugs (WHO-DD), proposes seriousness and expectedness, sets Day 0 and each market's due date, and drafts the narrative. A medical reviewer assesses causality; the agent never downgrades seriousness.
- Medical Information AI AssistantIdentifies who is asking and what, answers on-label questions from approved response documents with the source cited, sends off-label requests to medical affairs and side effects or product issues to safety or quality. It never writes free-text medical advice.
- Product Complaint AI AgentCaptures product, batch, complaint type and evidence, checks first for a hidden side effect, classifies severity, flags suspected counterfeit or tampering, detects clusters on the same batch, and drafts the response for QA approval.
- Quality & CAPA AI AgentStructures deviations from the plant app, email or out-of-specification results, proposes type and criticality from your SOPs, flags batch impact and repeat failures across sites, drafts CAPA options from similar cases and schedules effectiveness checks. QA approves; it never closes a deviation or releases a batch.
- Regulatory Submission AI AgentBuilds each market's checklist from the CTD structure, flags missing, expired or inconsistent documents, splits authority queries across experts, drafts responses from source documents and tracks licence transfers. The regulatory lead submits.
- Field Medical AI AgentTranscribes and structures MSL meeting notes and voice memos, checks for safety mentions and non-promotional compliance, files insights to CRM and routes any adverse event to pharmacovigilance.
- Clinical Trial Operations AI AgentTracks each site against plan for enrolment, queries and deviations, alerts study managers, chases sites, and sends serious adverse events to pharmacovigilance on the clinical clock.
- Supply Exception AI AgentIdentifies the product, batch, shipment and excursion duration from logger alarms or shortage signals, checks stability data, requests a quarantine decision from QA and informs customers and partners.
- SOP Harmonisation AI AgentAfter an acquisition, reads both organisations' SOPs, pairs those on the same topic, highlights real differences, drafts the harmonised SOP and tracks approval and training sign-off.
- Synergy Tracker AI AgentLoads each integration initiative with owner and target, compares ERP actuals with targets, flags slippage and updates the integration dashboard.
Workflows
- Adverse event to submissionIntake, coding, medical review and delivery to the safety database.
- Medical inquiry triageOn-label answer, off-label to medical affairs, or safety and quality route.
- Complaint to CAPAInvestigation, root cause, corrective action and effectiveness check.
- Cross-agent handoffOne call can open a complaint, safety case and deviation together.
- Cold-chain excursionStability check, quarantine decision and customer communication.
- Acquisition integrationDay 1 stabilise, Day 1 to 100 harmonise, then realise synergies.
Reports and dashboards
- Compliance clockCases and submissions against regulatory deadlines.
- Quality across plantsDeviations and CAPA by site.
- Complaint and inquiry trendsBy product, batch and market.
- Submission milestonesBy product and health authority.
- Integration and synergyTargets versus actuals.
- Agent performanceVolumes, confidence and review outcomes.
Add use cases for the rest of your operation
The pack covers Pharmaceuticals work. Service, scheduling, field service and finance come from use cases, each a separate line on your quote. Teams in this industry often add:
Included with every subscription
The pack and your use cases run on one platform, with one data model, one set of users and one audit trail.
See Pharmaceuticals running on your process
Price the pack with your use cases in two minutes, or let us show one priority workflow running with your systems.