AI FOR REGULATORY TEAMS
AI workspace for
regulated documents.
Most AI for life sciences stops at "chat over PDFs." Raycaster maps how every rule, spec, and paragraph connects, then keeps protocols, reports, and submissions in sync when anything changes.
REGULATED DOCUMENT WORKSPACE
One workspace for
all regulated teams.
Raycaster is designed for teams using RIM, DMS, and SharePoint folders. It connects rules, specs, and paragraphs across the dossier and keeps those connections current 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 creates cited redlines for every linked document it affects.
Updates ship in weeks, not months - cutting cycles, RTQs, and delay costs.
Raycaster turns regulatory operations into a traceable document workflow where each update has a source, owner, and approved change path.
HOW RAYCASTER WORKS
Built around the realloops 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 draft CSRs, Module 3 sections, and responses. Writers review every section before it lands in the file of record.
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.
See impact analysis across
your dossier.
Bring a live protocol, CSR, Module 3 section, or quality doc. We will show what changes, where it changes, and what evidence supports the edit.
Submissions in sync
with the science.
Don't miss out on Raycaster updates.
Solutions
