QRA AI
The AI reads every page of the dossier. Your regulatory team makes the call.
Today a dossier moves between six teams and five sign-offs, and gaps are found by hand, one template at a time. QRA AI puts pre-market, market and post-market work on one platform: it reads the full dossier, maps how the modules relate, checks every applicable market rule against the guideline it came from, and turns each gap into an owned action. Nothing is filed without a person deciding.
Every page read, nothing skipped.
Connect the SharePoint library where the dossier already lives, or upload from a local folder. The AI reads each module in full and works out what every document is, without your team changing how it files.
The parts that must agree, linked.
The dossier map shows which sections summarise, evidence or must agree with each other across Modules 1 to 5. The rules engine then works out which market rules apply to this dossier, which do not, and why.
Each gap shows where it was found.
An expired certificate, a missing sample declaration, a Module 1 letter still unsigned: every finding carries its evidence, then becomes an action with an owner and a due date.
The regulatory team has the final call.
Central, local and market RA each see what their role needs. Every decision is logged with who made it, when, and which model and guideline sat behind the recommendation.
Adossierpassesbetweensixteamsandfivesign-offs,andeverygapisfoundbyhand,onetemplateatatime.WhentheAIreadseverypagefirst,theregulatoryteamspendsitsmonthsondecisions,notonsearching.
Six teams, five sign-offs, and every gap found by hand
We mapped QRA AI to a working global RA SOP before writing a screen. Files pass back and forth between teams, gap analysis runs one template at a time, and in many developing markets the current guideline is not online at all. It lives with the local team.
One master dossier. Three formats. Every market.
Markets that follow the ICH CTD template share Modules 2 to 5 closely; Module 1 is where each market differs. That is what makes interchangeability work: move the same master dossier to a new target market, configure Module 1, and the rest carries over. ASEAN ACTD and national formats are mapped the same way.
The same three stages as your SOP, on one platform
QRA AI follows the process your regulatory team already runs. It does not ask anyone to change their SOPs; it removes the hand-offs between them. After submission, even a small change to the dossier is captured and its impact traced.
Four workspaces, one assistant, one audit trail
The dashboard shows every dossier, how far each module has been read and what is blocking it. Pre-market, market and post-market each get their own workspace, and the same assistant, roles and audit trail run across all of them.
Regulatory dashboard
Pre-market
Market
Post-market
AIM8 Copilot
Roles, audit trail, notifications
Nothing is filed that a person did not decide.
Every finding links to the page it came from and the rule it was checked against. Every decision records who made it, when, and which AI model produced the recommendation. QRA AI runs inside your own Azure tenant, connected to the SharePoint you already use, so the AI cost sits inside your existing Microsoft subscription and your data does not leave it.
Relations you can see
Proven on your dossier
A named RA approver
Your Azure tenant
Start with one dossier, one market
We configure QRA AI on a real dossier you have already prepared, for the first market you care about, mapped to your SOP and your roles. Your team sees its own gaps found with evidence before anything is decided.