Guidance Q&A bot
Cited answers across CDSCO, FDA, and EMA guidance documents.
For Regulatory Affairs
Draft, defend, and track submissions with a regulatory copilot.
An agent fluent in CDSCO, FDA, and EMA guidance — and in your dossier history.
−50%
first-draft time on Module 2 sections
100%
answers grounded in cited guidance
0
dossier data egress
Where it hurts
Submission velocity, with a paper trail.
Below are the friction points we hear from teams in this function — and the agents that resolve them.
- Guidance changes faster than teams can absorb.
- Drafting from a blank page each cycle.
- Cross-region inconsistency in submission language.
Module 2 drafter
First-draft generation for clinical overview and summary sections.
Question-response engine
Drafts responses to agency queries grounded in your dossier.
Why teams choose Evarx for this
- Indexed against current CDSCO + ICH guidance.
- Citation-linked answers — no hallucinated guidance.
- Per-region SLM fine-tunes available.