Regulatory affairs teams spend their weeks assembling dossiers from documents that already exist. We built an AI assistant that finds the right source, drafts the section and shows exactly where every sentence came from.
Every submission meant re-reading hundreds of pages — specifications, stability data, previous dossiers, guidance documents — to assemble sections that were 80% the same as last time.
The team could not use a general AI tool: an unattributed sentence in a regulatory document is a serious problem, and nothing could leave their tenancy.
Client: iCretegy
Approved documents, previous submissions and guidance indexed with permissions respected, so the assistant answers only from content the user is allowed to see.
Every generated paragraph carries a link to the source passage. Reviewers check the citation, not the whole document.
The assistant flags where a new submission differs from the approved precedent and where a required section is missing.
Nothing is submitted without a named reviewer approving it, and the approval is part of the audit record.
Mainstream, well-supported technology — chosen so the client’s own team can own it afterwards.
They understood our regulatory constraints before they wrote a line of code — and the citations are what convinced our QA team.
Head of Regulatory Affairs, iCretegy
One ERP for the operation and bots inside every client portal — eligibility, claims, rejections and posting.
Orders, fleet, warehouse and billing in one system, with live visibility from booking to proof of delivery.
A triage and information assistant grounded in approved clinical content, with escalation built in.
Tell us the number you need to move. We’ll tell you honestly what it takes and how quickly you’d see the first release.