A pharmacovigilance platform you can sell under your own brand
License the PVgenix safety database as your product: your name, your domain, your UI, and the fields and validation rules your clients actually need. We build and maintain the software and hand over the documentation package. You own the customer relationship.
- Branding
- Your name, logo, palette, domain, emails
- Deployment
- Dedicated single-tenant or multi-tenant
- Configuration
- Fields, validation rules, workflows
- Documentation
- VMP, URS, FS, DS, IQ/OQ/PQ, RTM, SOPs
What white-label pharmacovigilance software means here
White-label pharmacovigilance software is a safety database built and maintained by one company and sold under another company's brand. In a PVgenix white-label arrangement, you get a GxP-aligned ICSR platform carrying your name, logo, domain and interface styling, configured with the intake fields, validation rules and workflow states your clients require. PVgenix develops the application, provisions the environment and delivers the supporting validation documentation set. You hold the contract with the end client, set your own pricing, and own the commercial relationship.
- Your brand in the application, on the domain, and in system emails
- A dedicated single-tenant build, or a multi-tenant platform you operate and onboard your own clients into
- Configurable intake forms, field-level validation rules, picklists and no-code workflow states per tenant
- VMP, URS, FS, DS, IQ/OQ/PQ, RTM and SOP templates for the build we deliver, to support qualification in your environment
- MedDRA and WHO Drug Dictionary integrated into the application, licensed by you
Built for the company that wants a product, not a subscription
Three buyers ask for this, for three different reasons. If you are the team that will process cases yourself, the standard platform is the cheaper route.
CROs and PV service providers
You already run safety operations for a book of sponsors. A platform in your own name turns a cost line into a product line, and stops every sponsor conversation starting with someone else's software.
PV consultancies adding a product line
You sell expertise and want recurring revenue alongside it, without hiring an engineering team or taking on a multi-year build before the first customer.
IT and technology firms serving pharma
You have the client relationships and the delivery capability but not the domain-specific safety application. This gives you the product to wrap your services around.
What a white-label engagement delivers
Scope is agreed per client, and this is the shape of it. A substantial pre-built base already exists; the rest is configured or built against your requirements.
The application, in your identity
Branding is a configuration surface, not a patch we apply. Tenant branding, workflows and channels are administered from the console.
- Name, logo, colour palette and typography across the interface
- Your own domain, with system email templates in your voice
- Per-tenant branding where you operate a multi-client platform
- Reporter portal variants for HCP, patient and consumer intake
The safety capability underneath
The same codebase the hosted product runs on, so a white-label build is not a stripped fork that falls behind on releases.
- Intake through triage, data entry, quality and medical review
- MedDRA and WHO Drug Dictionary coding with admin version control
- Regulatory clock, reporting rules engine, E2B(R2) and E2B(R3)
- Built-in AS2 gateway, so no third-party gateway licence is needed
- Signal detection, aggregate reporting, literature monitoring, QMS
Configuration you control
The reason a rebranded product still fits your clients: the parts that differ between sponsors are admin-driven, not code changes.
- Configurable intake form fields and validation rules per tenant
- Admin-managed picklists and code lists
- No-code workflow and state builder per tenant or product
- Study and protocol configuration for study-specific reporting rules
- Notification, escalation and SLA-breach alerting
The documentation package
The deliverable that makes a rebranded platform defensible in front of your client's QA team and their auditors.
- Validation Master Plan, URS, Functional and Design Specification
- IQ / OQ / PQ protocols and a Requirements Traceability Matrix
- SOP templates and IT / infrastructure documentation
- Load-testing reports and performance qualification evidence
- IQ execution support and re-qualification support on releases
Who owns what
The single most useful thing to settle before a white-label contract is signed. Read the right-hand column as your obligations to your own client, because that is what it becomes.
| Area | PVgenix delivers | You own |
|---|---|---|
| Brand and identity | Your name, logo, palette, domain and system email templates applied across the application and any tenants under it. | The brand assets, the domain, and the customer-facing product name. |
| Application code | The platform codebase, feature build-out against your requirements, bug fixes and ongoing releases. | Defining the requirements, and acceptance against them. |
| Deployment and hosting | Environment setup, patching, backups and uptime on the hosted model. Dedicated builds are provisioned by our IT team. | The hosting region, and any internal-hosting or data-residency requirement your clients impose. |
| Tenancy | A dedicated single-tenant application and database, or a multi-tenant platform with logically isolated tenants that you provision yourself. | The commercial relationship with each end client, and who gets a tenant. |
| Fields and rules | Configurable intake forms, field-level validation rules, picklists and no-code workflow states, plus a reporting rules engine. | Which fields and rules your clients' SOPs and regulatory obligations actually require, and whether they are correct. |
| Validation documentation | VMP, URS, FS, DS, IQ/OQ/PQ, RTM and SOP templates for the build we deliver, plus IQ execution support and load-testing evidence. | Executing qualification in your environment, against your SOPs, and maintaining it across releases. |
| Dictionaries and licensed content | Integration of MedDRA and the WHO Drug Dictionary into the application, with admin-controlled version management. | Procuring and licensing those dictionaries and any other subscription content. |
| Pharmacovigilance decisions | The software that records the decision, the assessment logic it runs, and the audit trail behind both. | Causality, expectedness, seriousness sign-off, regulatory interpretation and QPPV responsibility. |
| End-client support | Second-line support to your team on the application itself, under the agreed SLA. | First-line support to your clients. We do not contact them or appear in front of them unless you ask us to. |
Nothing in the right-hand column can be moved left by contract. PVgenix is a software development provider, not a pharmacovigilance consultancy — a reseller who plans to pass PV responsibility through to us is buying the wrong thing, and their client's auditor will find that out before we do.
From first call to a platform in your name
The timelines below are IT provisioning and documentation handover only. They are not a computer system validation timeline and do not include your qualification execution, SOP authoring, UAT or PV go-live.
- Step 1
Scoping call
What you sell, to whom, and which modules that actually needs. This is also where we tell you if the standard platform would serve you better than a white-label build.
- Step 2
Requirement lock
URS agreed, brand assets handed over, deployment model chosen, and the field, rule and workflow configuration written down before anyone builds anything.
- Step 3
Build and provisioning
Initial hosted platform build runs about three days of IT setup plus about three days of documentation. A dedicated server is about three days setup and four days documentation. Agreed feature scope typically completes within roughly a month, depending on your requirements.
- Step 4
Handover and qualification support
Documentation package delivered, IQ execution supported, load testing evidence provided. Your QA or CSV team then runs qualification in your environment. After that, each new tenant you add self-provisions with about a day of documentation.
Three ways to license it
The difference between these is who operates the platform and how isolated each end client is — not which features you get.
Rebranded tenant
The fastest route to selling. You resell on our hosted platform, with your brand on the tenant.
- Your branding on a logically isolated tenant
- Hosting, patching, backups and uptime handled by PVgenix
- No infrastructure or DevOps on your side
- Documentation handover of about a day per tenant
Quoted per tenant, per year, with tiers as your client count grows.
Dedicated white-label build
Most commonClients with data-residency or isolation requirements, and resellers who want full control of the environment.
- Isolated application and database in your chosen region
- Your brand throughout, on your own domain
- Environment setup by our IT team
- Full documentation package for the delivered build
- EU, US or India region hosting
Quoted as a one-time build and setup fee plus an annual licence and hosting fee.
Your own multi-client platform
CROs and service providers who want to become the platform operator and onboard sponsors themselves.
- A multi-tenant platform under your brand
- Self-provisioning of new tenants from your admin console
- Per-tenant branding, workflows and channels
- Near-zero incremental setup per new client
- Per-sponsor compliance and submission dashboards
Quoted as a platform build fee plus a per-tenant licence as you onboard.
We do not publish a rate card, and a number invented for a web page is a number we would have to walk back on the call. Pricing depends on the modules in scope, the deployment model, how much is configured versus built fresh, and how many tenants you expect in year one. Tell us those four things and you get a real figure.
What a white-label licence is not
It is not a transfer of pharmacovigilance responsibility. PVgenix provides software development and delivery. All PV decisions, regulatory interpretation, safety assessments, SOP content and compliance obligations stay with you and your clients' qualified PV personnel. We are not a pharmacovigilance consultancy, a PV operations team, or a regulatory advisory service, and we will not act as your QPPV.
It is not a finished product that is qualified the day you receive it. We deliver the software, the environment and the documentation set that supports qualification. Executing that qualification against your environment, your requirements and your SOPs is your QA or CSV team's work, and it takes time beyond the setup timelines above.
It is not a source-code sale. You license the right to operate and resell the platform under your brand; PVgenix continues to develop and maintain the codebase, which is why your build keeps receiving releases instead of ageing into a fork nobody can update.
It does not include MedDRA, the WHO Drug Dictionary, or any other licensed terminology or data subscription. Those are procured and licensed by you or your client; we integrate them.
It is not the cheapest option if you are the end user. If your own team will process the cases and nobody outside your company needs to see your brand on the login screen, buy the platform and skip the licensing conversation entirely.
Answers before the call
The questions that come up in most scoping conversations. If yours is not here, ask it on the call.
Browse the full FAQYes. Tenant branding is an administered configuration surface, not a custom patch: your name, logo, colour palette and typography apply across the interface, the platform runs on your own domain, and system email templates carry your identity. Where you operate a multi-client platform, each tenant underneath can carry its own branding too.
Not from using it — the application, the domain and the emails carry your brand. What appears in your contracts, your quality agreements and your clients' own documentation is a commercial matter we agree in writing. Be aware that a client's auditor may ask who develops and hosts the system, and a supplier-qualification exercise will surface it, so most partners disclose the technology provider in their quality documentation even when the product is entirely their brand.
An initial hosted platform build is about three days of IT setup plus about three days of documentation handover. A dedicated server is about three days setup and about four days documentation. Delivery of the agreed feature scope typically completes within roughly a month, depending on your requirements. None of those figures is your validation timeline: they cover IT provisioning and documentation handover only, and your qualification, SOP authoring and UAT take additional time.
Yes, and this is usually what makes a rebranded platform viable across different sponsors. Intake form fields and their validation rules are configurable per tenant, picklists and code lists are admin-managed, and workflow states are built with a no-code designer per tenant or product. The reporting rules engine is configurable too, so which authority receives which case, in which format and within which timeline, is set up rather than coded. Deciding which rules are correct for your clients remains your responsibility.
PVgenix is validation-ready and audit-ready: it ships with a complete IQ/OQ/PQ documentation package to support client-led validation. 'Validated' is a state achieved only after qualification is executed in a specific client environment.
Third-party dictionaries and licensed content - including MedDRA and the WHO Drug Dictionary - are procured and licensed by the client. PVgenix integrates them into the application.
A dedicated single-tenant build can be deployed in your preferred environment, and EU, US and India region hosting options exist for GDPR and sponsor-contract requirements. Setup of a dedicated environment is performed by our IT team. Both the dedicated and multi-tenant models run from a single product codebase, so choosing isolation does not cost you feature parity.
Case data remains yours. Export is available through standard E2B transfer, and migration tooling covers extraction, field mapping and reconciliation beyond what plain E2B transfer carries — the same tooling used to bring data in from a legacy system. Exit terms, notice periods and the retention window are set in the licence agreement rather than left to be negotiated at the point you want to leave.
A multi-client system is an architecture question: can one platform hold many sponsors' data apart, with per-sponsor configuration and reporting. White-label is a commercial question: whose name is on the product you sell. Most CROs who want both end up with a multi-tenant platform under their own brand, which is the third engagement model on this page.
Tell us what you want to sell
Bring the modules you need, the deployment model, and roughly how many clients you expect in year one. We will tell you what the build looks like, what it costs, and whether a white-label licence is genuinely the right shape for it.