AI Agents across regulatory, quality, pharmacovigilance, medical information and supply.
WHY AUTOMATION FITS PHARMACEUTICALS
Batch reviews, regulatory submissions and safety reporting depend on complete, consistent documentation. Teams still spend hours gathering records, checking data and preparing files across systems.
Our AI agents automate that work end-to-end within your RIM, QMS, safety database and ERP, flagging gaps and preparing documentation for expert review. Release decisions and clinical assessments stay with qualified professionals.
WHAT WE DO FOR PHARMACEUTICALS
Agents assemble each submission and report. Your experts decide.
Source: Eurostat, sts_inpr_a (C21, C), 2025
AI agents check each executed batch record against the master, draft the deviation investigation and track CAPA. Your Qualified Person decides on a short list.
Source: EMA, Monthly statistics report, December 2025
Each change is classified, assembled into the submission sequence and tracked against its deadline in every market. AI agents prepare the work, and your regulatory team reviews and files.
Source: Eurostat, isoc_eb_ain2 (C21), 2025
Safety reports are triaged, medical inquiries answered from approved responses and serialization data uploaded, each step validated under Annex 11. AI agents keep a full audit trail, and a person signs off.
* Our fastest go-live. Timelines depend on the complexity of the project and its processes.
INSIDE A PHARMACEUTICAL COMPANY
We don't deploy generic software. We design AI Agents around the processes, tools and people of each function, then connect them where it matters. Click any department to explore.
Regulatory Affairs
Agents collect source documents, build and validate eCTD sequences, classify post-approval changes and prepare variation packages, track renewals and commitments and keep the RIM system current, so regulatory leads spend their time on strategy and agency dialogue.
Clinical Operations
Agents classify and file eTMF documents and chase gaps, check essential documents before site activation, track enrollment against plan, manage data queries and reconcile serious adverse events between systems, so study teams manage sites instead of paperwork.
Quality Assurance & GMP
Agents compare executed batch records against the master and flag exceptions, register and draft deviation investigations, track CAPA and effectiveness checks, administer change control and manage controlled documents. The Qualified Person releases; the agent prepares.
Pharmacovigilance & Safety
Agents capture and triage reports from every source, code events with MedDRA and draft narratives, submit expedited reports to EudraVigilance, screen the literature and compile PSURs, so the QPPV and medical reviewers assess instead of transcribe.
Medical Affairs & Medical Information
Agents screen publications, route promotional materials through medical, legal and regulatory review and check claims against labeling, compile MSL insights, and triage and draft answers to HCP and patient inquiries from approved standard responses, forwarding adverse events within timelines. Medical judgment stays with the physician.
Manufacturing, Supply Chain & Serialization
Agents build the demand and supply plan, prepare batch documentation, monitor inventory and expiry, handle cold-chain excursions for QA decision, prepare shortage notifications per country, upload pack data to the EU Hub and investigate verification alerts, so supply managers decide allocations instead of chasing status.
Procurement & CDMO Management
Agents run material requirements and purchase orders, coordinate orders, forecasts and documents with contract manufacturers, match invoices to orders and receipts, collect the documents QA needs to qualify suppliers and compute supplier scorecards, so buyers negotiate instead of administer.
Business Development & Licensing
Agents screen in-licensing opportunities against the strategy, index licensing data rooms against the due diligence checklist, coordinate functional due diligence, administer alliance committees and track milestones, royalties and partner reporting obligations, so deal teams negotiate instead of compile.
Commercial Operations & Market Access
Agents monitor tender portals and assemble bids, process wholesaler and hospital orders, compile pricing and reimbursement dossiers, monitor international reference prices, record HCP interactions against compliance rules and compile EFPIA disclosure reports, so commercial and access teams argue the value instead of formatting it.
Finance & Controlling
Agents process supplier and CDMO invoices, run the close checklist and reconciliations, compute rebate and clawback accruals, track R&D project costs and build the cash forecast, so controllers explain the numbers instead of assembling them.
HR & Training
Agents assign role-based GMP, GCP and GVP training on every new or revised document and track completion for inspections, maintain qualification records for QPs, auditors and operators, administer onboarding, process time and attendance and answer policy questions. Hiring and appraisal decisions stay with people.
IT & Data
Agents maintain validation documentation for GxP systems, provision access and run periodic reviews, prepare audit-trail review packages, monitor the interfaces between ERP, LIMS, safety, RIM and serialization systems and triage security alerts, so IT keeps the validated state at scale.
Agents run inside your infrastructure, on-prem, private cloud or hybrid. No data leaves your network without your approval. No dependency on us: it runs on infrastructure you control. The agent is yours to run, permanently.
You pay for the process automated, not consulting hours. If a process proves non-automatable, a voucher covers the next one.
Our fastest projects go live from 12 weeks; the plan for yours comes out of discovery, because it depends on the process and the systems it touches. Payback within one year for the large majority of projects.
PHARMACEUTICALS FAQ
Answers before the first call: the questions quality, regulatory and IT leaders ask us most.
As any other computerized system under EU GMP Annex 11: a documented intended use, risk assessment, test evidence, an audit trail on every action and output, and change control on every update. The agent's outputs are records a person reviews and approves; the Qualified Person's release, the QPPV's causality assessment and medical judgment are never automated.
How we integrate with each system →No. Our agents sit on top of Veeva Vault, TrackWise, MasterControl, Argus, LifeSphere, SAP and your serialization platform and treat them as the systems of record they already are. Where an integration does not exist, agents operate through the same interfaces your staff use today.
How we integrate with each system →Inside your environment: on-prem, private cloud or your own hybrid setup. Patient data from safety cases and clinical trials, unpublished dossiers and batch records stay in your environment by default, and access follows the same roles and information barriers you apply to people.
Where agents run and who holds access →They measure technical automation potential: how much of the human work in a process is technically automatable at full deployment with clean, integrated data. They are not a forecast of headcount reduction and not a promise of realized savings. Laboratory and manufacturing execution and regulated decisions are not counted.
How we integrate with each system →We do not automate them. Under the EU AI Act, screening candidates and evaluating performance are high risk and require human oversight. Agents track training and qualification records; hiring, appraisal and promotion decisions stay with your managers.
Fixed price per workflow automation. If during delivery we determine a process cannot be automated, you receive a voucher to automate a different process instead. Our fastest projects go live from 12 weeks; the plan for yours comes out of discovery, and validated GxP deployments add the qualification steps your SOPs require.
How we charge →
Book a 30-minute meeting with our team and discover what AI automation can do for your specific workflows.
