An illustrative scenario, and no price figures — deliberately
This is a modelled scenario, not a client case study, and you will not find a percentage saving or a monthly price below. We do not publish quantified cost comparisons because we cannot evidence them for your situation, and an unsourced "X% cheaper" claim is precisely what a finance review discounts. What this scenario gives you instead is the complete cost structure and a model you can populate with real quotes from every vendor you shortlist, including us.
Small pharma companies face an awkward asymmetry: the regulatory obligations of a large marketing authorisation holder, with a fraction of the resources. "Affordable pharmacovigilance software" is the obvious search, but it is the wrong frame — because licence price is a small and frequently misleading part of what compliant PV actually costs.
| Parameter | Modelled value |
|---|---|
| Organisation | Small pharma company, one marketed product |
| Markets | Two, with an ambition to add a third |
| Safety function | Two people, one of whom also covers regulatory affairs; QPPV function contracted |
| IT function | None |
| QA / CSV capacity | Contracted in when needed |
| Current state | Shared mailbox, spreadsheets, and a growing awareness that a first inspection would not go well |
| Case volume | Low, but rising as the product gains traction |
This is the structure. The point of laying it out this way is that vendors differ enormously on rows 2 to 6 while quoting only row 1 — and rows 9 to 12 are yours whichever way you go.
| # | Cost line | Who bears it | What to ask |
|---|---|---|---|
| 1 | Platform / licence cost | You, to the vendor | Is it per seat, per case, per tenant, or a flat platform fee? Per-seat pricing penalises adding a reviewer |
| 2 | Hosting / infrastructure | Vendor under a hosted model; you under an on-premise model | Is hosting included, and does the footprint scale with volume or step up in blocks? |
| 3 | Servers, installation, DevOps | You, under an on-premise model; nobody, under managed SaaS | For SaaS: confirm there is genuinely nothing to procure, install or patch on your side |
| 4 | Implementation / configuration | You, to the vendor | Fixed price or time-and-materials? What is in scope, and what is a change request? |
| 5 | AS2 / submission gateway | You — sometimes to a third party | Included in the platform, or a separately licensed product? A separate gateway also enters your qualification scope |
| 6 | Qualification support | You, to the vendor | Which documents are supplied (VMP, URS, FS, DS, IQ/OQ/PQ, RTM, SOP templates), and what execution support costs extra? |
| 7 | Data migration | You, to the vendor | Included, or priced separately? What does an E2B transfer cover and what needs field mapping? |
| 8 | Support tier | You, to the vendor | What response times, in which time zone, and what does the next tier up cost? |
| 9 | MedDRA licence | You, always | Confirm it is not included — it essentially never is. Budget it separately |
| 10 | WHO Drug Dictionary licence | You, always | Same — a client-procured subscription |
| 11 | Qualification execution, SOPs, UAT, training | You, or your contracted QA | This is frequently the largest single line for a small company, and no vendor removes it |
| 12 | Your people | You | The cost that automation redirects rather than removes |
The two rows that decide most comparisons
Row 5 and row 11. A separately licensed gateway adds both a recurring cost and an extra component in your qualification scope — for a two-person team, the second is worse than the first. And row 11 is usually the biggest number on the page for a small company, which is why "what documentation do you supply and what do we execute" matters more than the licence quote.
For the modelled profile — no IT function — this is the structurally important part. These are capability statements about our delivery model, not price claims.
- Row 3 goes to zero under multi-tenant SaaS: no servers to procure, no installation, no DevOps capacity needed on your side. Hosting, patching, backups and uptime sit with us.
- Row 5 is included rather than separate: the AS2 gateway is built into the platform, so there is no third-party gateway licence and no additional integrated component to qualify.
- Row 6 starts from a supplied documentation set — VMP, URS, FS, DS, IQ/OQ/PQ, RTM and SOP templates — rather than a blank page, which is the difference between a contracted QA resource reviewing documents and authoring them.
- Row 1 is structured without heavy per-seat enterprise licensing, so adding a second reviewer is not a licensing event.
What stays yours, in every scenario
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.
And the validation boundary
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.
The reason vendor comparisons produce confusing answers is that each quotes a different subset of the twelve rows. Force them onto the same basis.
- **Fix a three-year window, not one year.** Year one hides recurring cost and year one alone flatters whoever front-loads implementation.
- **Fix your own volume and user assumptions** and give the same numbers to every vendor, including a growth assumption for year three.
- **Ask every vendor to price all twelve rows explicitly**, marking any they do not provide as "not included" rather than omitting it.
- **Add your own rows 9 to 12 yourself** at the same values across all vendors, so they neither help nor hurt any single quote.
- **Ask what triggers a price change** — volume band, user count, additional market, additional tenant, model update.
- **Ask for the exit cost**: data export format, timeline and any fee. A low entry price with an expensive exit is a different deal than it appears.
- **Then compare total three-year cost divided by expected cases**, which is the only figure that means anything operationally.
The question that reveals the most
"Which of these twelve lines are not included in your quote?" Vendors who answer it precisely are usually the ones whose quote survives contact with reality. Vendors who redirect to feature discussion are telling you something.
For a single-product company, affordability is not the lowest licence fee. It is the combination of four things, and a cheap system that fails any of them is not cheap.
| Component | Why it matters more than licence price |
|---|---|
| No infrastructure burden | With no IT function, an on-premise model means hiring or contracting capability you do not have — a cost that dwarfs a licence difference |
| A documentation set to qualify against | Authoring a validation package from scratch with contracted QA is frequently the largest line item; starting from templates changes its size |
| Automation of the clerical load | Two people cannot absorb rising case volume by working harder; extraction, coding proposals and derived deadlines are what let volume grow without headcount |
| Room to grow without replatforming | Adding a market, a product, or a first clinical study should be configuration. Replacing the system in two years is the most expensive outcome available |
- What PVgenix costs. Pricing is quoted per engagement based on deployment model, scope and volume — ask us, and hold the answer against the twelve-row model above.
- What you will save. We have no evidenced comparison figure for your situation, and we are not going to invent one.
- How long your qualification will take or cost. That depends on your QA capacity and SOP maturity, not on us.
- Whether a cheaper option exists. Possibly. The twelve-row model is designed to let you find out on a like-for-like basis.
Source note
The company profile in this scenario is a modelled illustration, not a client record. The delivery-model statements — managed hosting with no client-side infrastructure, a built-in AS2 gateway rather than a separately licensed product, the supplied VMP/URS/FS/DS/IQ/OQ/PQ/RTM and SOP template set, and pricing without heavy per-seat licensing — are drawn from our platform capability documentation. No cost figure, saving percentage or price appears in this scenario because none can be evidenced generically.
Next: how much does pharmacovigilance software cost in 2026 for the market-level cost breakdown by system category, PV software for small and mid-size pharma for the capability view, and scenario: time to first submission for the timeline equivalent of this exercise.
Frequently asked questions
Common questions
Because we cannot evidence them for your situation. Pricing depends on deployment model, scope, volume and tenant count, and any generic percentage saving would be an unsourced claim that a finance review would rightly discount. What the scenario provides instead is the complete twelve-line cost structure and a method for forcing every vendor onto the same basis, which is more useful than a number we made up.
Twelve lines, of which the licence is one: platform licence, hosting, servers and installation and DevOps, implementation and configuration, submission gateway, qualification support, data migration, support tier, MedDRA licence, WHO Drug Dictionary licence, your qualification execution and SOP and UAT and training effort, and your people. Vendors typically quote line one while differing enormously on lines two to eight, and lines nine to twelve are yours regardless of which vendor you choose.
MedDRA and WHO Drug Dictionary licences, which are procured and licensed by the client in essentially all arrangements; your qualification execution, SOP authoring, UAT and training; and your own staff. For a small company the qualification and SOP line is frequently the largest single item on the page, which is why what documentation a vendor supplies matters more than the licence quote.
Two reasons, and for a small team the second is worse. It adds a recurring licence cost, and it adds another integrated third-party component inside your qualification scope — meaning more to qualify initially and more to re-assess when either product changes. A gateway built into the platform keeps transmission on the same system and the same audit trail as the case that produced the file.
Fix a three-year window rather than one year, fix your own volume and user assumptions and give the same figures to everyone, ask each vendor to price all twelve cost lines explicitly and mark anything they do not provide as "not included", add the client-borne lines yourself at identical values across all quotes, ask what triggers a price change, ask for the exit cost and data export terms, then compare total three-year cost divided by expected case volume.
It should not. Cost position is largely driven by architecture and hosting model rather than by reduced controls — a modern cloud-native platform runs on a more efficient infrastructure footprint than an older architecture requires. What you should verify is that role-based access control, electronic signatures, tamper-evident audit logging and a complete IQ/OQ/PQ documentation package are present regardless of price, and that qualification is executed against your own environment.