Answer a Health Authority question from your own submission history, with the source behind every line.
It finds the evidence behind each question in your dossier and accepted precedent, then drafts a sourced response for your specialist to review and approve. Your team stays in charge at both ends.
See it on a study in your pipelineSee how it works
~50
less drafting effort per question: 10 hours before, 4 to 5 now
~40
faster to find the right evidence than manual search
~2,000
active users across regulatory, CMC, quality and clinical, on 32 product families
Every query is a race against a fixed clock
The evidence usually exists somewhere in the organisation. Finding it, checking it and assembling it is where the time goes.
Deadlines don’t move
Several questions land at once across several programmes, each on its own clock, however complex they are.
The evidence is scattered
Prior submissions, correspondence, technical documents and functional repositories, with no single place to search.
Every question starts from zero
Without searchable precedent, teams re-research questions they have already answered, pulling in clinical, safety, CMC and quality each time.
Your team receives the question and your team sends the answer. We do the finding and drafting in between.
The solution never receives a Health Authority question directly and never submits a response.
From question to sourced answer
Five steps. A named specialist signs off before anything leaves.
1. Question logged
Your regulatory team
2. Evidence retrieved
Automated
3. Sourced draft written
Automated
4. Specialist reviews
Regulatory, CMC, clinical or safety
5. Your team submits
Your regulatory team
Product A · CTD 3.2.P.5.6 · Justification of specifications
Response due in 30 days
“Justify the proposed acceptance criterion for impurity B, with batch and stability data.”
The proposed criterion for impurity B is supported by all registration batches, which stayed within the limit at release1. Levels did not increase meaningfully over 24 months of storage2. The same criterion was accepted in a previous response for this product3.
- Batch analysis summary, 3.2.P.5.4
- 24-month stability report
- Approved precedent response, Product A
On every draft
Faithfulness0.94
Citation accuracy0.97
Evidence coverage0.81
Cited relevance0.89
✓ Approved by CMC regulatory specialist
Response set locked
Every action in a hash-chained audit trail
Added to your precedent store
Illustrative example. Scores are indicative signals for the reviewer, not a substitute for their judgment.
Built to hold up in an inspection
Not just in a demo.
Your data only
Grounded in your own historical protocols. Nothing is shared between clients and no design leaves your environment.
Your environment
Hosted inside your environment or by Excelra, whichever your infrastructure policy allows.
Human sign-off, always
Review is mandatory before anything finalises. It supports your regulatory team and replaces no part of it.
Works with your tools
Sits alongside your existing document and submission systems rather than replacing them.
Built with GxP and 21 CFR Part 11 expectations in mind. Every read, edit, approval and rejection is written to a hash-chained, timestamped audit trail.
See it on a question like yours
Tell us what your Health Authority correspondence looks like today. We will walk you through the retrieval, the draft and the audit trail on a comparable example.
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Built in the Excelra AI Lab
Domain scientists and engineers turning a client conversation into a working prototype, on one governed architecture.
40
AI solutions across the R&D value chain
8
live in production with clients
2–4
to a working prototype
