Pharmacovigilance software and safety database development in Chandigarh
PVgenix Private Limited builds, hosts and supports GxP-aligned safety databases from its office in Chandigarh — for pharmaceutical companies, CROs and biotech across Chandigarh, Mohali and Panchkula, the wider region, India, and export markets.
Why teams in the region look for a local PV technology partner
The Chandigarh region sits next to one of India's largest pharmaceutical manufacturing bases — the Baddi-Barotiwala-Nalagarh belt in Himachal Pradesh, plus units across the tricity itself. Much of that output is exported, which brings US, EU and UK pharmacovigilance obligations with it.
Export markets set the compliance bar
A manufacturer shipping to the US, EU or UK is held to FDA, EMA and MHRA expectations wherever its safety team sits. The safety database has to meet that bar.
Spreadsheets that have outgrown themselves
Many regional companies still track adverse events in spreadsheets and email. That works until an inspection asks for an audit trail with before and after values.
A safety database nobody local can build
Teams that need a safety database built or adapted to their process often find the nearest engineers who understand GxP and Part 11 are in another city, or another country.
Vendors a flight and a timezone away
When a submission deadline is hours away, a vendor whose support opens after your working day ends is an operational risk, not an inconvenience.
CROs serving overseas sponsors
Tricity CROs and PV service teams are audited by overseas sponsors who expect demonstrable data segregation between clients and an evidence-grade audit trail.
Enterprise pricing built for other budgets
Global enterprise safety platforms are priced for originator margins. Against generic and CRO economics, the cost per case rarely survives a business case.
PVgenix is a pharmacovigilance software company based in Chandigarh. We run a hosted, GxP-aligned safety database covering the full ICSR lifecycle, and our engineering team builds custom safety databases and regulatory tooling where a product does not fit — with development and support in the same city and the same working day as you.
What we build and run from Chandigarh
Two ways to get a safety database — use ours, or have us build yours — and the components in between.
Hosted safety database (SaaS)
A ready, GxP-aligned pharmacovigilance platform: intake, triage, coding, assessment, review and submission on one case record, with no client-side IT setup.
See how it worksCustom safety database development
Our engineering team builds safety databases, LIMS and regulatory tooling to your requirements, with URS, FS, DS, IQ/OQ/PQ and a traceability matrix delivered alongside the code.
See how it worksICSR case management
Multi-channel intake, duplicate detection, MedDRA coding, causality assessment, and quality and medical review with a complete audit trail.
See how it worksE2B(R3) submission
E2B(R2) and E2B(R3) generation with documented routes to FDA (FAERS via ESG), EMA (EudraVigilance) and MHRA, a built-in AS2 gateway, and CIOMS I and MedWatch 3500A outputs.
See how it worksAI-assisted case intake
Extraction from PDFs, emails and narratives with per-field confidence scores and coding proposals, always under a human review gate.
See how it worksMulti-client operation for CROs
An isolated tenant per sponsor with its own reporting rules, workflows and datasheets, plus per-sponsor compliance reporting.
See how it worksWhite-label licensing
Run the platform under your own brand if you offer PV services to your own clients and want the system to carry your name.
See how it worksAPIs and components
E2B(R3) generation, MedDRA coding and reporting rules as licensable components for a safety system you already run.
See how it worksWhat a Chandigarh-based team changes
Specific operational differences that follow from the people building your system being here.
Support while you are still at work
Development and support sit in Chandigarh, so an urgent question before a submission deadline reaches people who are at their desks.
Requirements workshops across a table
For teams in Chandigarh, Mohali and Panchkula and the nearby manufacturing belt, scoping and requirements sessions can happen in person, by appointment, rather than only over video.
Data residency is a deployment choice
India, EU and US region hosting, and a dedicated single-tenant deployment where a contract requires physical isolation.
Built to export-market expectations
Designed around 21 CFR Part 11, EU GVP, GAMP 5 and GxP, with an IQ/OQ/PQ documentation package and VMP, URS, FS, DS, RTM and SOP templates supporting your qualification.
Priced for this market
A low platform and hosting cost without heavy per-seat enterprise licensing, quoted per engagement on deployment model, tenants and case volume.
Investing in local drug safety talent
We run PVgenix Academy, a free, live, online programme in ICSR case processing taught inside our own safety platform.
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 a pharmacovigilance software company headquartered in Chandigarh. PVgenix Private Limited builds, hosts and supports the PVgenix safety database and develops custom drug safety software. We are a technology company: we do not provide outsourced pharmacovigilance services such as case processing, QPPV or regulatory consulting.
PVgenix Private Limited, Plot No. 337, WorkYard, Industrial Area Phase II, Chandigarh 160002, India. We serve clients across Chandigarh, Mohali and Panchkula, the rest of India, and internationally. Meetings at the office are by appointment — use the contact page to arrange one.
Yes, in two ways. Most companies use our hosted, GxP-aligned safety database, which needs no client-side IT setup. Where your process or data model does not fit a product, our Chandigarh engineering team builds a custom safety database to your requirements, with the documentation set needed to support qualification. We will tell you at scoping which one fits.
Yes. We work with teams across Chandigarh, Mohali and Panchkula and the surrounding pharmaceutical manufacturing region, as well as clients elsewhere in India and abroad. The platform is delivered online, so location does not limit what you get — it only makes in-person meetings easier.
No. PVgenix provides software development only — the application, the environment and the supporting documentation. We are not a pharmacovigilance consultancy, PV operations provider or regulatory advisory service. All PV decisions, safety assessments, SOP content and compliance obligations stay with you and your qualified PV personnel, including the QPPV function.
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 outputs, and a built-in AS2 gateway. Indian domestic requirements and other market-specific routes are assessed and scoped per client agreement, so ask us about your specific obligations rather than assuming coverage.
We run PVgenix Academy, a free, live, online programme in ICSR case processing taught inside our safety platform, which gives you hands-on work to show an interviewer. We do not guarantee placement and we have no placement cell. See the Academy page for eligibility and the next batch.
Talk to the team in Chandigarh
Request a 30-minute demo — online, or at our Chandigarh office by appointment — and we will walk through your markets, your reporting obligations, and whether you should use our safety database or have us build yours.