Don't comply? We know why.
Regulatory complexity,
Structured.
Comeply is the regulatory intelligence instrument that watches the rules, checks them against your documentation, and saves you a fortune doing it.
The problem
Regulations don't wait.
Neither should you.
Regulatory landscapes evolve constantly. GMP updates, new ICH guidelines, EMA revisions — your Quality and Regulatory Affairs teams are expected to track it all, interpret it, and keep your PQS aligned. Manually. That's not oversight. That's firefighting.
The solution
From regulatory noise to structured intelligence.
Comeply monitors the regulators so you don't have to. We extract every requirement from the latest guidance, structure it against your quality documentation, and show you exactly where your gaps are — before an inspector does.
Platform features
Every capability you need.
Regulatory Monitoring
Every regulatory authority, every update — tracked, categorised, and delivered in one configurable feed. No manual scanning, no missed changes.
EMA & FDA sync
Live sync · auto interpret · impact score
ICH change alerts
Live sync · auto interpret · impact score
PMDA updates
Live sync · auto interpret · impact score
Health Canada
Live sync · auto interpret · impact score
Version control
Live sync · auto interpret · impact score
Contextual Controls
We don't just surface the rules — we structure them. Every regulatory requirement is broken down into its precise, actionable core so your team knows exactly what's being asked.
Sync mode: continuous
Latency: 0.9s
Impact Assessment
Map your identified requirements against your internal documentation and see exactly where you're covered, where you're partially aligned, and where your gaps lie — before an auditor does.
Crosswalk
Automatically identify what changed between document versions — what's new, modified, or removed — so you understand the full impact of a regulatory revision the moment it drops.
Version history
Compliance Signals
Configure your regulatory feed to match your organisation's exact scope. Cut through the noise and surface only what's relevant to your operations and markets.
Domain filter
All domains visible
Structured AI
AI that produces structured, explainable outputs with validation layers — built for regulated environments where you need to know not just the answer, but why.
Structured output
Audit Readiness
Every assessment generates a structured compliance report with coverage scoring and readiness indicators — giving you a clear, documented basis for audit preparation.
Audit trail
Regulatory Monitoring
Every regulatory authority, every update — tracked, categorised, and delivered in one configurable feed. No manual scanning, no missed changes.
EMA & FDA sync
Live sync · auto interpret · impact score
ICH change alerts
Live sync · auto interpret · impact score
PMDA updates
Live sync · auto interpret · impact score
Health Canada
Live sync · auto interpret · impact score
Version control
Live sync · auto interpret · impact score
Contextual Controls
We don't just surface the rules — we structure them. Every regulatory requirement is broken down into its precise, actionable core so your team knows exactly what's being asked.
Sync mode: continuous
Latency: 0.9s
Impact Assessment
Map your identified requirements against your internal documentation and see exactly where you're covered, where you're partially aligned, and where your gaps lie — before an auditor does.
Crosswalk
Automatically identify what changed between document versions — what's new, modified, or removed — so you understand the full impact of a regulatory revision the moment it drops.
Version history
Compliance Signals
Configure your regulatory feed to match your organisation's exact scope. Cut through the noise and surface only what's relevant to your operations and markets.
Domain filter
All domains visible
Structured AI
AI that produces structured, explainable outputs with validation layers — built for regulated environments where you need to know not just the answer, but why.
Structured output
Audit Readiness
Every assessment generates a structured compliance report with coverage scoring and readiness indicators — giving you a clear, documented basis for audit preparation.
Audit trail
Regulatory Monitoring
Every regulatory authority, every update — tracked, categorised, and delivered in one configurable feed. No manual scanning, no missed changes.
EMA & FDA sync
Live sync · auto interpret · impact score
ICH change alerts
Live sync · auto interpret · impact score
PMDA updates
Live sync · auto interpret · impact score
Health Canada
Live sync · auto interpret · impact score
Version control
Live sync · auto interpret · impact score
Contextual Controls
We don't just surface the rules — we structure them. Every regulatory requirement is broken down into its precise, actionable core so your team knows exactly what's being asked.
Sync mode: continuous
Latency: 0.9s
Impact Assessment
Map your identified requirements against your internal documentation and see exactly where you're covered, where you're partially aligned, and where your gaps lie — before an auditor does.
Crosswalk
Automatically identify what changed between document versions — what's new, modified, or removed — so you understand the full impact of a regulatory revision the moment it drops.
Version history
Compliance Signals
Configure your regulatory feed to match your organisation's exact scope. Cut through the noise and surface only what's relevant to your operations and markets.
Domain filter
All domains visible
Structured AI
AI that produces structured, explainable outputs with validation layers — built for regulated environments where you need to know not just the answer, but why.
Structured output
Audit Readiness
Every assessment generates a structured compliance report with coverage scoring and readiness indicators — giving you a clear, documented basis for audit preparation.
Audit trail
AI & governance
AI built for regulated environments. Not borrowed from them.
Comeply's AI operates within defined contextual controls and validation layers — purpose-built for GxP environments where structured, explainable outputs aren't optional, they're required. We augment your regulatory expertise; we don't replace your judgement.
Every output is explainable
Requirement traces link each insight back to the source guidance.
Built-in audit trails
Validated outputs record changes, decisions, and evidence as you go.
Scoped to your regulatory domain
Contextual controls align outputs to authorities and frameworks you select.
Value delivered
Confidence you can prove.
Oversight
One consolidated view of your entire regulatory landscape.
Traceability
Every requirement linked back to your internal processes.
Alignment
Continuous consistency between your PQS and evolving standards.
Adaptability
Respond to regulatory updates in hours, not weeks.
The manifesto
Most compliance platforms focus on static monitoring and manual checklists.
Wefocuson:adaptiveintelligence,precisionalignment,andconfidentcompliance.
Enterprise engagement
Designed for regulated enterprises.
Comeply partners with compliance leaders to build a continuous regulatory operating system, tailored to your jurisdictions and quality frameworks.
Baseline Assessment
We establish where you stand — mapping your existing documentation against the regulatory requirements relevant to your scope and quality framework.
Platform Deployment
Comeply is configured to your organisation — connecting your internal documentation and regulatory sources so gap analysis runs continuously, not manually.
Executive Visibility
Decision-makers get a clear, structured view of compliance status — gaps, coverage, and regulatory changes — without needing to read the source documents themselves.
Enterprise onboarding · compliance intelligence
Services
We don't just hand you software. We get you compliant.
We configure the platform around your organisation — not the other way around.
Regulatory scoping workshops
Define the frameworks, authorities, and products that shape your compliance perimeter.
Requirement mapping & validation
Translate guidance into structured requirements mapped to your PQS and SOP evidence.
Ongoing advisory support
Stay aligned as regulations shift with expert guidance and continuous updates.
Tailored to your jurisdictions and quality frameworks.
Ready when you are
Book a demo.
Real answers, real savings.
Every signal, every SOP, every regulation — mapped in one place.
No commitment required.
Response within 24 hours.