Rematiq
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For Regulatory Affairs

Defensible by default.

From regulatory intelligence to design control and submissions, REMATIQ automates the work that proves a product is ready. Keep timelines, demonstrate compliance, pass every audit and submission.

Value

Less grunt work. More great work.

Rematiq connects fragmented regulatory knowledge and turns it into clear, actionable direction. No ambiguity in interpretation. No uncertainty in submissions. Every decision grounded, traceable, defensible.

Your week, today

  • Global requirements inconsistently collected. Teams don’t know what applies where and changes are not implemented.

  • Changes cause delays. Every 30 minutes a regulation changes. 12 months to implement. Every gap creates delays.

  • Submissions take months. Compilation of 1000s of documents across dozen of documents take up your best people.

  • Authority Agents find every gap. Notified body and FDA agents identify every gap in every single part of your documentation.

Your week on Rematiq

  • Global requirements, always up-to-date. Collect and organize what needs to be true in every market from day 1.

  • Regulatory changes automated. Automatic processing of all changes across products and processes with full compliance.

  • Submission documentation generated. Every deliverable for every requirement. One click.

  • Audit and agent-ready, every day. Fine-granular evidence for every single requirement, easily retrievable by agents.

Use Cases

Leave chance no chance.

Every interpretation grounded. Every deliverable traceable. Every submission defensible. Every answer ready.
Regulatory Intelligence

Regulatory Intelligence

AI identifies all applicable regulatory requirements and checks your documentation for gaps in real-time.
Compliance Check

Compliance Check.

Ensure compliance of any deliverable in your submissions against global applicable requirements.
Submission Generation

Submission Generation.

Create any document for a dossier with a click of a button. Compliant with all requirements. Following your internal guides.
Traceability Graph

Traceability Graph.

Automatically link extracted data objects of any regulation, process, test or product documentation to easily facilitate change management and migrations.
Already in production

The world’s leading RA teams innovate with REMATIQ.

Real impact measured in large-scale deployments at the world’s most innovative companies.
MedTech

93% faster Regulatory Intelligence

Regulatory Intelligence teams use REMATIQ to create a seamless link from regulation to product and process. Fully automated, more precise then humans.

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Pharma

14 weeks → 7 weeks

Global PSPV, Clinical Trials and Manufacturing teams accelerate regulatory impact assessments by weeks while experiencing 75% efficiency gains.

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Where REMATIQ sits in your RA workflow

From first idea to submission. Nothing falls out of trace.

REMATIQ doesn’t replace your RIM, PLM or eQMS. It connects them, keeping decisions, requirements, evidence, and deliverables coherent across every stage of the lifecycle.

Talk to an AI specialist.

Kim Bergstrand

Head of Sales

Book a 30 min call

  1. 01

    Regulatory Intelligence. Monitor all global requirements and detect relevant changes in real-time. Nothing missed, no noise added.

  2. 02

    Regulatory Requirements. Systematically collect, extract, link and update regulatory requirements for each product and process across the whole company. Pre- and post-market.

  3. 03

    Compliance checks. Stay audit-ready at all time by checking every product and process for compliance.

  4. 04

    Submission generation. Agents create documentation based on your templates and on your regulators expectation in real-time.

If your team spends more time formatting than building, we should talk.

Book a demo