Regi's intelligent workflows help you deliver faster, more consistent client outputs across UKCA, EU MDR and FDA, without scaling headcount.
Products and markets, without losing editorial control.
And version confusion on every engagement.
That clients can actually maintain after handover.
You can know the regs inside out and still lose billable time to inputs, reconstruction, and inconsistency.
Every client arrives with different artefacts, definitions and maturity. Intended purpose and claims drift across documents, evidence and PMS linkages get patched in late, and when the product changes, you're pulled back into rewrite cycles.
That creates real friction: slower delivery, repeated effort across engagements, harder QA, inconsistent outputs across consultants, and handovers that don't stick. Clients come back with the same questions at the next milestone.
AI Assist suggests hazards and flags input gaps grounded in applicable guidelines and your internal data, so your professional judgement gets applied at the right points rather than spent on reconstruction work.
Document Wizards guide every engagement through the same step-by-step creation process for PMS plans, clinical evaluation reports, and risk management files, so every project follows the same "right work, right order" flow regardless of consultant or client maturity.
Turn recommendations into a practical plan with connected outputs, so clients don't leave with a slide deck and a pile of documents they can't maintain.
Capture the "why" behind key decisions as you go. Outputs stay defensible for notified bodies, auditors and diligence, without reverse-engineering later.
Each client lives in its own device-specific workspace with full data isolation — no cross-contamination between engagements. Regi creates a coherent set of artefacts and change notes that clients can keep current as the product evolves, reducing ongoing dependency on ad-hoc reconstruction.
Consistent, audit-ready client artefacts, delivered faster and with a clean handover built in.
Create an isolated client workspace and set the frameworks in scope. No data leaks between engagements.
Guided wizards capture inputs systematically. AI grounds suggestions in applicable guidelines; clients stay on pace without slowing the engagement.
Inputs captured early flow automatically into risk, evidence, and PMS — the whole file stays coherent without manual reconciliation.
Traceability links update as the file evolves. Post-market monitoring is set up and ready for the client to operate after handover.
AI triages adverse events and flags potential signals — the client gets a functional PMS operation, not just a plan on paper.
Every output carries your review and sign-off. What you hand over is defensible because you built it.
See how Regi fits your consulting practice — book a demo with your use case in mind.