Regulatory intelligence · eQMS · Life sciences
Comeply follows the regulations that apply to you, reads them against your documents, and runs the quality system they land in. Add it to the QMS you have, or start with ours.
Supported by
Skylab
SkylabSkylabTwo ways to start
I already have a QMS
Add the regulatory layer on top of Veeva Vault, MasterControl or a similar system. Comeply follows the regulations and reads them against the documents you already have. Nothing to replace.
See Compliance IntelligenceI need a QMS
Start with a full eQMS that has the regulatory landscape built in. Documents, training, events, CAPA, change, audits, risk and suppliers, in one place.
See the quality systemOr use both. They share the same documents, traceability and audit trail.
Compliance Intelligence
The platform
01Monitoring
Comeply continuously watches your regulatory sources and captures each relevant compliance signal the moment it lands.
13 regulatory sources, including EMA, FDA, ICH, MHRA and PMDA, harvested daily. Every guideline, revision and notice is captured into one structured feed, tagged by source, document type and GxP (Good Practice) domain, and filtered by the scope rules you set.
02Extraction
Each update, and each existing document, is broken down into its individual requirements and details.
Comeply reads each source and extracts requirement-level statements with their context: scope, obligations, and references. The same extraction runs across your existing controlled documents, so new and old are described in the same structured language.
03Impact & gaps
Comeply maps each requirement against your QMS, so you can see whether a change affects you and which documents it lands in.
By connecting to your internal QMS (SOPs, policies, work instructions), Comeply compares each requirement to what you already have in place. It surfaces which documents a change impacts and pinpoints the gaps between the requirement and your current controls.
04Remediation
Every gap becomes a clear, owned action, from finding to documented remediation.
Each gap turns into a structured, assignable action carrying its source requirement, the impacted document, and an owner. Your team moves from a flagged gap to documented remediation without losing the traceable thread.
Compliance Intelligence modules
Comeply Quality System
A full eQMS, live in production. The regulatory landscape Comeply already monitors sits inside it, so a regulatory change can move into change control, documents, training and CAPA without leaving the system.
Twelve registers today, and we keep adding.
Explore the quality systemWhy one platform
Documents, training, events, CAPA, change, audits, risk and suppliers live together instead of in eight separate tools.
The regulatory intelligence sits inside the quality system, not in a tool beside it that someone has to reconcile by hand.
A regulatory change, the affected SOP, the change request, the training and the CAPA are linked records.
Electronic signatures bound to the record they were signed against, a full audit trail, and sensible defaults you confirm and adjust.
Starting out
Every quality register from day one, guided setup instead of a blank page, and regulatory intelligence built in. Serious capability at a startup-friendly price.
See the startup pathServices
Comeply does the reading, cross-checking and tracking. Our team and trusted quality professionals help with the parts that need hands-on experience.
Drafting and improving SOPs, and closing the gaps the platform finds.
Turning findings into a prioritised plan, and working through it with you.
Getting the quality system configured and your documents into it.
Practical quality and compliance help, when you need it.
Configuring Comeply around your products, processes and regulatory scope.
Controlled documents translated, delivered with a translation partner.
Enterprise engagement
We map your existing documentation against the regulatory requirements relevant to your scope and quality framework.
We configure Comeply to your organisation and connect your documentation and regulatory sources, so gap analysis runs continuously.
Decision-makers get a clear view of gaps, coverage, and changes without reading source documents.
AI & governance
Requirement traces link each insight back to the source guidance, so a reviewer can check where it came from.
Outputs record changes, decisions, and evidence automatically as you go.
You choose the sources and frameworks, and outputs stay inside that scope.
Security & data protection
The infrastructure is hosted in the EU, data handling follows the GDPR, and formal ISO 27001 certification work is underway.
ISO/IEC 27001
Information security management
In progress
ISO/IEC 42001
AI management systems
On our roadmap
GDPR
EU data protection
In accordance
EU AI Act
Responsible AI requirements
In alignment
Comeply is a platform for quality and regulatory teams in life sciences. It combines regulatory intelligence and a full quality system in one place, so you can see what the rules require and manage how your company meets them.
No. Comeply's intelligence layer works on top of the QMS you already have, such as Veeva Vault, MasterControl or similar systems. You keep your system of record and add Comeply for the regulatory intelligence. If you would rather have one system, you can also run your quality system in Comeply.
Yes. Controlled documents, training, quality events, CAPAs, change requests, complaints, audits, risk files, management reviews, suppliers and equipment are all live. Approvals, releases and closures are signed electronically, and each signature is bound to the record it was made on.
Most quality systems are separate tools for separate processes, and none of them understand regulation. In Comeply the regulatory landscape is built in and everything is connected. A regulatory change can be traced to the affected documents, the change request, the training and the CAPA, all in one platform.
Yes. Comeply is built for startups that are just getting started as well as large enterprises. You switch on the modules you need, start from sensible defaults, and add more as you grow.
Every finding quotes your own documents, and the quotes are checked against the source text before a finding can rely on them. Your people confirm or reject suggested matches, so traceability is a reviewed record. Answers from Atlas are informational and are not regulatory advice.
No. Comeply does not train AI models on your documents or data. Your documents are used to run your own analysis, inside your own isolated environment.
Each customer runs in its own isolated environment, hosted in the EU, and audit records cannot be altered after the fact. A private cloud option is available on request. You can read more in our security overview.
Public regulations from 13 sources, including FDA, EMA, ICH and MHRA, are monitored automatically. Paywalled standards are uploaded by you under your own licence and go through the same analysis.
Book a demo and we will walk through Comeply based on your regulatory scope. If you want to test it on your own documents, ask us about a pilot. The quality system has guided setup, so you are not starting from a blank page.
Yes. Our team and trusted quality professionals can help with SOP writing, closing gaps, set-up and migration, GMP and GxP support, and translation of controlled documents.
Pricing depends on which modules you use and the scope of your setup, so it fits companies at any stage. Book a demo and we will give you a clear proposal.
Ready when you are
