Enterprise-grade pharmacovigilance, without enterprise complexity
A company with one marketed product answers to the same regulations as one with two hundred. PVgenix gives a small safety team the full ICSR lifecycle, the submission routes, and the audit trail an inspector expects — without an IT function, a multi-month rollout, or per-seat enterprise licensing.
The asymmetry small pharma actually faces
Regulatory obligations do not scale with company size. The expedited reporting clock, the periodic report schedule, the literature monitoring duty, the audit trail expectation — all identical whether you have three people in safety or three hundred. The result is a squeeze that shows up in the same places for almost every company at this stage.
Two options, neither of which fits
Enterprise platforms are priced and scoped for large marketing authorisation holders. Spreadsheets and shared mailboxes are free and will not survive a first inspection. Most companies sit uncomfortably between the two for longer than they should.
The QPPV is wearing several hats
When the person accountable for pharmacovigilance is also doing regulatory affairs and quality, time spent re-typing case data from PDFs is time not spent on the assessments only they can make.
No IT function to carry a deployment
Enterprise rollouts assume infrastructure, DevOps capacity, and an internal team to run environments. If you have none of that, the implementation model matters more than the feature list.
Deadlines tracked by memory and calendar
One serious unlisted case creates an expedited obligation with a hard deadline. When the clock lives in someone's head or a spreadsheet, a late submission is a matter of when, not if.
The audit trail does not exist until it is needed
Evidence spread across mailboxes, shared drives, and Word documents becomes a reconstruction project the moment an inspector asks who assessed a case and against which datasheet version.
Qualification looks impossible at this size
Computer system validation reads like a large-company activity. Without a documentation set to work from, small teams either over-engineer it or quietly skip it — and the second one is a finding.
PVgenix closes the gap from the other direction: the full capability set of an enterprise safety system delivered as managed SaaS, provisioned in days with no infrastructure on your side, with the regulatory clock and audit trail running automatically and a complete IQ/OQ/PQ documentation package to work from — at a cost profile a single-product company can actually justify.
What a small safety team gets
Not a cut-down edition. The same platform larger clients run, with the parts a marketed-product portfolio needs configured to your products and markets.
Multi-channel intake without a call centre
A dedicated intake mailbox, a web reporter portal for HCPs and patients, plus file and API intake — so reports arrive in a structured queue rather than an inbox someone has to watch.
See how it worksAI-assisted extraction and coding
Case data extracted from PDFs, emails, and narratives with per-field confidence scoring, plus MedDRA coding proposals — the data entry your qualified people should not be doing by hand.
See how it worksListedness against your datasheets
Version-controlled CCDS/CCSI, SmPC, and USPI, so an expectedness call is always traceable to the datasheet version in force on the assessment date — one of the first things an inspector tests.
See how it worksThe regulatory clock, run for you
Automatic Day 0 determination and 7-day / 15-day timeline calculation per reporter region, with due-date tracking and alerts before a deadline is breached.
See how it worksSubmission without a gateway purchase
E2B(R2)/E2B(R3) generation, CIOMS I and MedWatch 3500A outputs, and an AS2 gateway built into the platform — with acknowledgements reconciled back to the case.
See how it worksPeriodic reports from your own case data
PBRER/PSUR and PADER support with line listings and summary tabulations generated from one interval query at the data lock point — instead of a manual assembly exercise each cycle.
See how it worksLiterature monitoring you can evidence
Scheduled searches with automated screening and reviewer-confirmed ICSR identification, plus an audit trail of the search strategy and every screening decision — the GVP obligation most often thinly documented.
See how it worksQuality management built in
CAPA, deviation, and change-control tracking tied to case processing, so quality findings have somewhere to live other than an email thread.
See how it worksWhy this works at small scale
The constraint for a small team is rarely capability — it is overhead. These are the specific overheads PVgenix removes.
Nothing to procure, install, or patch
Fully hosted and managed: no servers, no installation, no DevOps capacity needed on your side. Hosting, patching, backups, and uptime are ours. That removes the single biggest blocker for a team without an IT function.
Live in days, not quarters
The initial SaaS platform build takes around three days plus three days of setup documentation handover. That covers IT provisioning only — your qualification execution, SOP authoring, UAT, and operational readiness sit on top and are led by you.
Pricing that does not punish a small team
No heavy per-seat enterprise licensing and a low hosting footprint, so cost follows actual need rather than a licence model designed for a different size of company.
A documentation set to qualify against
VMP, URS, FS, DS, IQ/OQ/PQ, RTM, and SOP templates are provided to support client-led qualification — so a small QA function has a starting point rather than a blank page.
Inspection evidence as a by-product
Every create, read, update, and delete captured with who, what, when, and before/after values, plus electronic signatures. The evidence accumulates while people work instead of being assembled afterwards.
Room to grow without replatforming
The same platform covers signal detection, additional markets, and clinical-trial cases if your pipeline expands — so a second product or a first study does not mean a new system.
Answers before the demo
The questions that come up in most evaluations. If yours is not here, ask it on the call.
Browse the full FAQYes — that is a core use case. Because it is delivered as managed SaaS with no client-side infrastructure and pricing that is not built around per-seat enterprise licensing, the cost and setup profile suits a single-product company. You get the same platform larger clients run, configured to your products and markets, rather than a reduced edition.
For multi-tenant SaaS, no infrastructure at all. There are no servers to procure, nothing to install, and no DevOps capacity required — hosting, patching, backups, and uptime are handled by us. What you do need to provide is the pharmacovigilance side: your reporting rules and regulatory interpretation, your reference safety information, your SOPs, your qualification activities, and your qualified PV personnel.
It is more achievable with a documentation set to work from than from scratch. PVgenix is delivered validation-ready and audit-ready with a complete IQ/OQ/PQ package plus VMP, URS, FS, DS, RTM, and SOP templates, and installation qualification execution support is available. Qualification itself remains environment-specific and client-led: it is executed against your environment, requirements, and SOPs, and owned by you or your QA/CSV team. Scope timelines accordingly rather than assuming the vendor timeline is the whole picture.
Yes. PBRER/PSUR and PADER are supported, with line listings and cumulative and interval summary tabulations generated from a single interval query at the data lock point, and every figure traceable to the case versions included. The medical writing and benefit-risk interpretation in the report remain with your qualified PV personnel — the platform supplies the data and the traceability.
Documented submission support covers FDA (FAERS via the ESG gateway), EMA (EudraVigilance), and MHRA, with E2B(R2) and E2B(R3) generation, CIOMS I and MedWatch 3500A form outputs, and an AS2 gateway built into the platform. Additional routes and market-specific requirements are assessed and scoped per client agreement — ask us directly about any market that is critical to your portfolio rather than assuming coverage.
Nothing needs replacing. The same platform covers additional products and markets through configuration, and clinical-trial safety — SUSAR identification and expedited handling, blinding and unblinding workflow, and study and protocol configuration — is part of the same system on the same case structure. Signal detection and additional aggregate report types are available as your data volume and obligations grow.
Yes. Third-party dictionaries and licensed content — including MedDRA and the WHO Drug Dictionary — are procured and licensed by you. PVgenix integrates them, including admin-controlled version management and auto-coding with manual override, but does not supply or license them. Budget for these separately when comparing total cost across vendors.
See PVgenix sized to your team
Request a 30-minute demo and we will walk through your products, your markets, and the reporting obligations that actually apply to you.