Building the system
for certainty.
Hope is not a system. Rematiq pairs frontier AI reasoning with a traceability engine and domain validation, so R&D, regulatory, and quality teams ship compliant products. First time right, every time.
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- Faster R&D
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- Faster reg intel
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- Faster assessments
TRUSTED BY TEAMS BUILDING REGULATED PRODUCTS
Regulatory complexity is exploding. The old playbook can't keep up.
Standards multiply across markets, requirements fork with every revision, and the burden lands on the experts you can least afford to lose to paperwork.
rise in regulatory requirements
Across global frameworks over the last decade.
of engineering time lost
Spent reformatting, tracing, and re-verifying documents.
missed clause is enough
To stall a submission, trigger a recall, or fail an audit.
Rematiq is the definitive AI system for life sciences, where every claim is sourced, every change is traced, and certainty is engineered in.
Not a chatbot bolted onto a document store. A purpose-built compliance system that keeps a frontier model honest with verifiable, auditable structure.
One system, three places it pays off.
R&D, Regulatory Affairs, and Quality Management work from the same connected source of truth, with measurable gains at each step.
Turn regulations into engineering requirements
Agents read the applicable standards, draft structured requirements, and link each one back to its source. Engineers spend their time designing, not transcribing.
- Auto-drafted requirement specs from live regulation text
- Every requirement traceable to its clause
- Design changes propagate through the graph instantly
faster requirement development
A knowledge graph and the agents that work it.
The Rematiq Knowledge Graph
The connective tissue of compliance. Ask a question and follow the answer from any regulation, through the requirements it drives, to the records that prove it.
Connected by design
Regulations, requirements, and records live as one graph, not siloed files.
Automated traceability
Every link is maintained as your products and the rules around them evolve.
Full version history
See what changed, when, and which obligations it touched.
Agentic workflows
Agents draft requirements, verify them against the source, and trace each claim, with a person in the loop for every decision that matters.
Draft, verify, trace
Agents do the legwork; experts approve at every human-in-the-loop gate.
Cited, not invented
Every output carries verbatim citations back to the governing source.
Artifact-based
Work in the structured artifacts your QMS already understands.
Draft
doneGenerated requirement spec
Verify
doneChecked against EU MDR + ISO 13485
Trace
doneLinked to 4 source records
An embedded domain team, not a login and good luck.
Regulatory and quality experts work alongside yours to integrate, validate, and adapt the system to how you actually operate.
- 01
Integration
We connect Rematiq to your existing QMS and data.
- 02
Validation
GxP validation runs so the system is qualified for use.
- 03
Workflow discovery
We map your real processes, not a generic template.
- 04
Change management
We bring your teams along so adoption actually sticks.
Built to pass the audit, by design.
Data governance, validation, and traceability aren't features bolted on later. They're the foundation the rest of the system is built on.
GxP validated
Qualified for use in regulated environments, with documented validation.
Auditable traceability
A defensible record of every link, decision, and revision.
Verbatim citations
Every AI claim is grounded in the exact governing source text.
Human-in-the-loop
Experts approve. The system assists, it never signs off alone.
Stop formatting.
Start building.
Book a walkthrough with our domain team. We'll map Rematiq to your products, your standards, and your QMS, and show you what certainty looks like.
- 30-minute tailored walkthrough
- Mapped to your regulatory scope
- No commitment, no slide deck