Your regulatory documents, traced from draft to variation.
Kildra drafts, checks and maintains your filings, with a source behind every value so your experts can make the call.
Book a demo- Pharma
- Biotech
- CDMOs
- Regulatory Affairs
- CMC
- Quality
Less hunting. More deciding.
“The most experienced people usually know.”
Each value opens at its source. Reviewers confirm it where it stands.
A traced gap list before you submit: inconsistent, out of date, or no stated basis.
Every affected item, traced and flagged, plus a suggested variation type with its guideline.
The rule, the prior commitment and the source page, in one place.
Checking shouldn't cost more than doing.
“It’s a lot more work to find out where it was hallucinating than to do it ourselves.”
Product preview. Illustrative data.
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Traced to the rule and the page
Every value links to the rule behind it and its source.
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Gaps are shown, not hidden
Missing values? Kildra flags it.
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Honest about coverage
A quiet all-clear is never the default.
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Your experts own the judgment
Kildra advises. Your experts decide and sign.
Built by people who have defended CMC filings and shipped AI at scale.
Andrew MacKessack-Leitch
Co-founder, Science & Quality
11+ years in CMC, authoring dossiers and defending them in front of regulators across Europe, the US and Asia.
Trygve Fjelleng
Co-founder, Product & AI
13+ years at Klarna, building AI and data products from first idea to scale.
Shape Kildra with us.
Kildra is in development. We're building it with a few Regulatory, CMC and Quality teams as design partners.
Book a demoDesigned for the security and quality standards regulated work demands.
Hosted in the EU, isolated to your organisation, and zero AI training on your data. We comply with GDPR and the EU AI Act today. ISO 27001, SOC 2 Type II, ISO 42001, Annex 11 and Part 11 are on our roadmap.
Planned
ISO 27001
Certification of our information security management system.
Planned
SOC 2 Type II
An independent audit of how we secure and manage data across our systems.
Planned
ISO 42001
Certification of how we build, run and govern AI.
Planned
EU GMP Annex 11 and FDA 21 CFR Part 11
Support for validating Kildra as a computerised system in GxP work.
Compliant
EU AI Act
Kildra is not a high-risk AI system. AI-made work is marked in the audit trail, and our team is trained in AI literacy.
Compliant
GDPR
Based in Sweden, we operate under GDPR, with data hosted in the EU.
Common questions
What is Kildra?
Kildra helps Regulatory, CMC and Quality teams draft, check and maintain their regulatory documents, with a source behind every value. It holds specifications, acceptance criteria and regulatory commitments, links each to the rule behind it and the document it came from, and shows what moves when something changes.
Can we use it today?
Not yet. Kildra is in development, and we're building it with a few design partners who will use it first and shape what we build. Get in touch to join.
Who is Kildra for?
Regulatory, CMC and Quality teams at pharma, biotech and contract manufacturing companies: anyone who has to work out what a change affects across their documents.
We already have an AI assistant. Why this?
An answer without a source has to be re-checked line by line. Kildra works from a structured record of your documents: every value is tied to its rule and its source, gaps are shown as gaps, and it tells you where it isn't confident it has seen everything.
Does it replace our experts?
No. Kildra takes over recall and cross-checking. Your experts make the argument, decide what is material, and own the submission. Every suggestion shows its source, so people see why, not just what.