India-built pharmacovigilance software for Indian pharma, CROs and biotech
PVgenix is built and supported in India by PVgenix Private Limited, with India region hosting available and a cost profile designed for the Indian market — while covering the E2B(R3) submission routes Indian companies need for their US, EU and UK export obligations.
What Indian safety teams are usually working against
Indian pharmaceutical companies and CROs carry an unusual combination of obligations: domestic requirements, plus the full weight of US, EU and UK pharmacovigilance for export markets — often on cost structures set by competitive generic pricing rather than by originator margins.
Export markets set the compliance bar
A company shipping to the US and EU is assessed against FDA and EMA expectations regardless of where it operates. The system has to meet that bar, not a lower one.
Enterprise licensing priced in another currency
Global enterprise platforms are priced for originator budgets. Against Indian generic and CRO margins, the cost per case rarely survives a serious business case.
Sponsor and partner audits from overseas
Indian CROs and contract manufacturers are audited by overseas sponsors who expect evidence-grade audit trails and demonstrable data segregation — not assurances.
Data residency written into contracts
Some sponsor agreements require data to remain in a specific jurisdiction, and others require it to stay in India. Without hosting options, those clauses become lost contracts.
Support in another timezone
When a submission deadline is hours away, a vendor whose support desk opens as your working day ends is a structural operational risk.
Growing volume, flat headcount
Export-driven case volume tends to grow faster than safety headcount, and the gap is filled by manual data entry until something is automated.
PVgenix is built in India for exactly this profile: a GxP-aligned platform covering the full ICSR lifecycle with the documented FDA, EMA and MHRA submission routes export markets require, AI-assisted extraction to absorb volume growth, India region hosting where contracts require it, and development and support in your timezone — at a cost base built for the Indian market rather than converted into it.
What Indian teams get
The same platform, capability set, and documentation our international clients run — built and supported locally.
Full ICSR lifecycle
Multi-channel intake, duplicate detection, triage, coding, assessment, quality and medical review, and submission on one connected case record with a complete audit trail.
See how it worksExport-market submission routes
E2B(R2) and E2B(R3) generation with documented support for FDA (FAERS via the ESG gateway), EMA (EudraVigilance) and MHRA, plus CIOMS I and MedWatch 3500A form outputs.
See how it worksBuilt-in AS2 gateway
The gateway is part of the platform, so there is no separate gateway product to license in foreign currency or add to your qualification scope.
See how it worksAI-assisted extraction and coding
Extraction from PDFs, emails and narratives with per-field confidence scoring and MedDRA coding proposals under mandatory human review gates — the automation that absorbs export-driven volume growth.
See how it worksIndia region hosting
India, EU and US region hosting options, so a sponsor contract requiring data to remain in a particular jurisdiction is a deployment decision rather than a blocker.
See how it worksMulti-client operation for CROs
Isolated tenant per sponsor with independent reporting rules, workflows and datasheets, plus per-sponsor compliance reporting — the operating model Indian CROs need.
See how it worksAudit evidence for overseas sponsor audits
Role-based access control, tenant isolation, encryption, e-signatures and tamper-evident audit logging with before/after values — the evidence an overseas sponsor's auditor asks for.
See how it worksAggregate reporting and surveillance
PBRER/PSUR, PADER and DSUR support, literature monitoring with AI-assisted screening, and signal detection using PRR, ROR, BCPNN/IC and EBGM.
See how it worksWhat being India-based actually changes
Not a marketing claim — these are the specific operational differences that follow from the company being here.
Your timezone, not an overnight ticket queue
Development and support sit in India, so an urgent question hours before a submission deadline reaches people who are at work rather than a queue that opens after your day ends.
Residency clauses become answerable
India, EU and US region hosting options, and a dedicated single-tenant deployment where a sponsor requires physical isolation in a named jurisdiction.
Priced for this market, not converted into it
A low platform and hosting cost with no heavy per-seat enterprise licensing — which is what makes the business case work against competitive generic and CRO margins.
Compliance built to export-market expectations
Designed around 21 CFR Part 11, EU GVP, GAMP 5 and GxP, with a complete IQ/OQ/PQ documentation package plus VMP, URS, FS, DS, RTM and SOP templates supporting client-led qualification.
Rapid provisioning for new work
The initial SaaS platform build takes about three days plus three days of setup documentation, and each additional tenant is self-provisioned — useful when a sponsor contract is won on a short mobilisation timeline. IT setup only; your qualification sits on top.
Serving India and beyond from one product
Indian clients run the same codebase as international ones, so capability and behaviour do not diverge and an overseas sponsor is not being shown a different 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. PVgenix is built and delivered by PVgenix Private Limited, an India-based software development company, with development and support located in India and clients served both in India and internationally. India region hosting is available alongside EU and US options.
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 a built-in AS2 gateway. Indian domestic submission requirements, and any other market-specific route, are assessed and scoped per client agreement — so ask us directly about the specific authorities and formats you are obliged to report to rather than assuming coverage. We would rather give you a straight answer during evaluation than have you discover a gap during implementation.
Yes. India region hosting is available, alongside EU and US options, to support GDPR and sponsor-contract residency requirements. Where a sponsor agreement requires physical isolation in addition to a named region, that client can be deployed as a dedicated single-tenant environment with an isolated application and database, running the same codebase as the shared multi-tenant service.
That is a core use case. Each sponsor is an isolated tenant with its own reporting rules, workflows, code lists, dictionary versions and reference safety information, and per-sponsor compliance metrics such as on-time submission rate are computed from the submission records themselves. For overseas sponsor audits, the relevant capabilities are tenant isolation you can describe precisely, tamper-evident audit logging with before/after values, and a documentation set you can reference — see our CRO pages for the full operating model.
PVgenix is positioned at a materially lower platform and hosting cost than legacy enterprise systems, without heavy per-seat licensing, which is what makes it viable against Indian generic and CRO margins. Pricing is quoted per engagement based on deployment model, tenant count, case volume and agreed scope. Note that MedDRA and WHO Drug Dictionary licences are procured separately by you and should be budgeted for in any comparison.
No. PVgenix provides software development only — we build and deliver the application, the environment setup and the supporting documentation. We are not a pharmacovigilance consultancy, a PV operations provider, or a regulatory advisory service. All PV decisions, regulatory interpretation, safety assessments, SOP content and compliance obligations remain with you and your qualified PV personnel, including the QPPV function.
PVgenix Private Limited operates from the Chandigarh tricity region — Chandigarh, Mohali and Panchkula — and serves clients across India and internationally. Development and support are located in India, so client teams in Indian time zones work with people in the same working day.
Talk to an India-based team
Request a 30-minute demo and we will walk through your markets, your reporting obligations, and the hosting model your contracts require.