One molecule, from an IQVIA export to a filed dossier.
This page follows that path exactly, because that is how PharmX is built. Not a module list — a sequence, with a named decision at each step and the evidence that decision requires.
Pick your role. See your slice first.
The same platform looks different from every chair. Choose yours and see what you would open on, what it fixes for you, and the modules behind it.
Pipeline review and shortlist status
Portfolio decisions made on evidence, not the loudest voice
The datasets arrive before the opinions do.
Quarterly IMS and IQVIA exports, regional market-pull files and reference pricing load into PharmX and attach to the molecules they describe. From that point the conversation is about what the data says, not about whose deck was more recent.
Molecules carried in the reference build include empagliflozin, semaglutide, osimertinib, apixaban, rivaroxaban, dolutegravir, vortioxetine and cetirizine.
Eight criteria. Every head scores every molecule against the same eight.
This is the part that usually happens in a room and disappears afterwards. In PharmX it happens in the system, so a shortlist can still be explained a year later — including by someone who was not in the room.
| Criterion | The question it forces | Usually owned by |
|---|---|---|
| Technical feasibility | Can we actually make this, at this quality, with what we have? | R&D / formulation |
| Manufacturing complexity | What does it cost in capacity, changeover and containment? | Operations |
| Market attractiveness | Is the market large enough and growing, on the data we loaded? | Marketing / strategy |
| Competitive position | Who else is already filing, and where does that leave us? | Strategy |
| NPV / ROI outlook | What does the money look like across the development horizon? | Finance |
| Investment required | What has to be committed before we know whether it works? | Finance / operations |
| Clinical differentiation | Is there a real reason a prescriber changes behaviour? | Medical |
| Regulatory risk | What could delay or block the filing, and in which market? | Regulatory affairs |
Strategy mapping
Candidates are placed on an attractiveness quadrant first, so the committee argues about a short list rather than a long one.
Consolidated shortlist
The reference build carries quarterly pipeline reviews, a GCC expansion screen and an oncology deep-dive as separate shortlists.
Multi-stage approval
The shortlist is signed off through staged electronic signature, with reason and meaning captured against each signer.
A gate opens when its evidence exists.
Not when a status turns green in a review meeting. These are the gates and the artefacts each one requires, as configured in the reference build for an oral solid dosage product.
Initiation
Patent landscape assessed, OEL and ADE established, PDE documented, RMP form completed, and the SAP WBS raised so development spend has somewhere to sit from day one.
Product development
Formulation development runs with its evidence attached — method validation, stability protocol and the development report against the target product profile.
Scale-up and exhibit batch (OSD)
The SU and EB gate. Batch manufacturing records, bioequivalence study reports and the quality overall summary must be in place before filing work begins.
Filing
Country dossiers assembled from the versioned library and pushed through the eCTD publishing gateway, with submission status tracked per market.
The PAF register sits across all four, showing every product's stage, owner and ageing in one view — so a stalled file is visible without asking anyone.
Documents that carry their own history.
Every controlled document is versioned in place with the approval that made it effective attached to it. When regulatory asks which version supported which submission, that becomes a lookup rather than an investigation.
| Document class | Where it is used |
|---|---|
| Quality overall summary (QOS) | Dossier module 2 |
| Bioequivalence study report | Filing evidence |
| Stability study protocol | Development and filing |
| Method validation report | Analytical package |
| Batch manufacturing record | Exhibit batch gate |
| SOP — cleaning validation | Site compliance |
The part your quality head will ask about first.
PharmX is built to be a system of record in a regulated environment, so the controls are not a later module. These are the specific ones, so the conversation can start at the right level.
Electronic signature and audit trail
Signing captures who, what, when and the meaning of the signature. The audit trail is hash-chained, so integrity is verified rather than asserted — and trail integrity verification is itself one of the qualification tests.
IQ, OQ and PQ shipped as scripts
Server installation qualification, workflow engine operational test, e-signature module functional test, database backup and restore verification, audit trail integrity validation, and an end-to-end submission performance test under production-like load.
MFA and role-based scope
Multi-factor authentication, roles that map to how your organisation actually approves things, and an approvals queue per user rather than a shared mailbox.
Four connections at go-live
SAP ERP product master, SharePoint document library, Active Directory sync and the eCTD publishing gateway — so master data and identity are never maintained twice.
Six functions, one record.
The value only appears when all six are in the same system. A shortlist approved by four of them is still an email thread.
| Function | What they open first |
|---|---|
| Business head | Pipeline review and shortlist status |
| R&D and NPD | NPD projects and gate evidence |
| Regulatory affairs | PAF register, dossiers, submissions |
| Quality assurance | Audit trail, validation, controlled documents |
| Intellectual property | Patent landscape at initiation |
| Finance | Investment required, NPV outlook, WBS spend |
Walk one molecule through it with us.
Bring a product that is currently stuck between functions. We will run it through the gates on screen and show you exactly where the evidence should have been.