AI FOR REGULATORY TEAMS
The operating system
for regulated documents.
Most AI for life sciences stops at "chat over PDFs." Raycaster is a change-aware OS that maps how every rule, spec, and paragraph connects—then keeps your protocols, reports, and submissions in sync when anything changes.
REGULATORY INTELLIGENCE LAYER
One workspace for
all regulated teams.
Raycaster doesn't replace your RIM or DMS. It sits on top of them as a regulatory intelligence layer that understands how every rule, spec, and paragraph connect—and keeps those connections up to date when the science or guidance moves.
Regulatory submissions
From CTD sections to global variations, keep requirements, content, and history in one change-aware workspace.
Clinical & medical writing
Draft and reconcile protocols, CSRs, and summaries with cross-document consistency baked in.
CMC & quality
Track specs, methods, deviations, and change control with clear impact on Module 3 and site documentation.
Labeling & safety
Keep core labels, local labels, and safety narratives aligned with claims, evidence, and signals.
WHY RAYCASTER
A single, change-aware
workspace over all your
regulated documents.
The problem isn't drafting the first version—it's stopping thousands of regulated documents from drifting apart every time a spec or rule changes.
Problems
Teams dig through 100-page PDFs and SharePoint folders just to make small updates.
Every agency has different rules; tracking them in spreadsheets is chaotic and error-prone.
Small inconsistencies—values, wording, missing files—stall approvals and trigger RTQs.
Typical update cycle: 3–6 months for what should be minor changes.
All obligations and documents live in one change-aware workspace.
See what each agency needs instantly, no manual cross-referencing.
One change to the source updates every linked document with cited redlines.
Updates ship in weeks, not months—cutting cycles, RTQs, and delay costs.
Raycaster turns regulatory operations from a manual, error-prone drag on progress into a predictable, data-driven engine for faster approvals.
HOW RAYCASTER WORKS
Built around the real
loops of regulatory work.
From first question to final redlines, Raycaster follows the same path your teams already use—just without the manual glue.
Research
Ask any regulatory question and get cited answers, pulled from FDA, EMA, ICH guidance and your own standards. No more hunting through PDFs and folders.
Draft
Use your CTD templates and product data to auto-draft CSRs, Module 3 sections, and responses. Writers start from a near-complete draft instead of a blank page.
Change
Update a spec or paragraph once, see every impacted document, and apply cited redlines across protocols, labels, and submissions. Drift is caught by design, not heroics.
BUILT FOR THE TEAMS AROUND THE MOLECULE
Built for the teams
who live in the details
Raycaster adapts to how cross-functional teams actually work—whether you're coordinating global submissions from HQ or running CMC changes out of a single site.
Global regulatory
Coordinate global submissions and variations without losing track of regional nuance.
CMC & manufacturing
Link specs, methods, and Module 3 content directly to the changes happening on the floor.
Clinical & safety
Keep protocols, CSRs, and safety narratives aligned with the same evidence.
Labeling & medical
Translate complex science into aligned, compliant claims across markets.
Ready to stop fighting
your documents?
See how Raycaster keeps every protocol, report, and module on the same path as your molecule—and gives your teams weeks back on every submission.
Drug development,
accelerated.
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