Current view
12
applicable requirements
Compliance Operating System · Europe
European compliance that grows with your operation.
ComplyPharm turns EU GMP and GDP requirements into cited answers, controlled quality workflows and inspection-ready evidence — with qualified people in control.
EU
shared core
EU · EEA
European operations
HITL
human approval
Medicinal cannabis lifecycle Light
EU COREEU GxPINSPECTION
01 · Shared EU core
Requirements start with a trusted source.
EU GMP · GDP · Annex 11
One controlled chain
Your process, step by step
From documents to a release decision.
Add the batch, check quality and licences in parallel, fix any gaps, then make one clear decision. Select a step to see what happens there and what comes next.
Complete capability map
One operating system for Europeancited regulatory intelligence.
Turn an EU requirement into a verified answer, its operational context and the exact action it creates.
Connected proof
EU GMP Annex 1
Version 2022
Primary sources verifiedNext action
Review the impact on SOP-QA-014
OpenEuropean by design
A shared European core. The right obligations for each operation.
ComplyPharm connects EU-level guidance with versioned applicability, authority evidence, licences, activity type and the decision trail required by your quality system.
Human control is part of the system
AI helps locate risk. Qualified people make the decision.
Roles and responsibility
Each controlled step has an owner and the appropriate level of access.
Controlled approval
A suggestion never becomes a regulated decision without an authorised person.
Defensible history
Changes, comments, source evidence and approvals remain attached to the process.
Built on primary sources
Regulatory knowledge should always lead back to the authority.
Open a source to understand what it governs, why it matters operationally and what your team should verify before acting.
Practical answers
Questions compliance teams ask first.
See ComplyPharm in action
Requirement, evidence and the next decision in one view.
Regulatory knowledge becomes accountable work: an owner, a deadline, a controlled record and a complete trail for the inspector.
European compliance workspace
Audit trail activeAudit trailBatch in progress
CP-EU-2026-0810
Distribution · European Union · Responsible Person
EU · EEA
Batch dossier
Every record enters one controlled batch dossier.
Batch dossier
3 / 4
documents ready
Next action
Attach distribution authorisation
Owner: Regulatory Operations · due today
Every response retains its source, jurisdiction and applicable version.
Licences, training, reviews and actions have accountable owners and visible status.
Connected evidence tells a complete story without rebuilding it before the inspection.
Plans and service
Three plans. Three levels of human service.
Every plan carries the controlled core — documents, products, suppliers and the Annex 11 audit trail. What changes is how much of the operation the platform runs, and how much of our time comes with it.
Essential
For an importer or distributor putting controlled documentation in order for the first time.
Price on request
Service level
Standard support
Human reply within 2 business days
- Named user accounts: up to 5
- Controlled documents with versions and approval status
- Product records, permits and linked documentation
- Supplier qualification and written confirmations
- SOP library, versions and distribution
- Annex 11 audit trail with hash-chained entries
- Compliance overview and evidence export
- Google Drive as a controlled document destination
Sales opening soon
The plan is prepared in our shop but not published yet. Write to us and we will tell you the day it goes live.
Operations
Most complete valueFor a growing company running its own quality system day to day.
Price on request
Service level
Guided support
Human reply within 1 business day
- Named user accounts: up to 25
- Controlled documents with versions and approval status
- Product records, permits and linked documentation
- Supplier qualification and written confirmations
- SOP library, versions and distribution
- Annex 11 audit trail with hash-chained entries
- Compliance overview and evidence export
- Google Drive as a controlled document destination
- Pre-arrival batches with RP/QP release workflow
- Lab results and CoA review
- Deviations and CAPA
- Licence portfolio with expiry alerts
- Training matrix per role and SOP
- AI label reading for product records
Sales opening soon
The plan is prepared in our shop but not published yet. Write to us and we will tell you the day it goes live.
Inspection
For a multi-site organisation preparing for inspection with a controlled import chain.
Price on request
Service level
Partner support
Human reply within 4 business hours
- Named user accounts: unlimited
- Controlled documents with versions and approval status
- Product records, permits and linked documentation
- Supplier qualification and written confirmations
- SOP library, versions and distribution
- Annex 11 audit trail with hash-chained entries
- Compliance overview and evidence export
- Google Drive as a controlled document destination
- Pre-arrival batches with RP/QP release workflow
- Lab results and CoA review
- Deviations and CAPA
- Licence portfolio with expiry alerts
- Training matrix per role and SOP
- AI label reading for product records
- Import dossier — five-section assembly per shipment
- BtM narcotics ledger and BfArM annual report
- Relabeling and repackaging records
- Logistics and packing lists
- Regulatory calendar and intelligence feed
- AI drafting: SOP generator, Annex generator, gap analysis
Sales opening soon
The plan is prepared in our shop but not published yet. Write to us and we will tell you the day it goes live.
What each plan unlocks
| Capability | Essential | Operations | Inspection |
|---|---|---|---|
| Controlled core | |||
| Controlled documents with versions and approval status | |||
| Product records, permits and linked documentation | |||
| Supplier qualification and written confirmations | |||
| SOP library, versions and distribution | |||
| Annex 11 audit trail with hash-chained entries | |||
| Compliance overview and evidence export | |||
| Google Drive as a controlled document destination | |||
| Quality operations | |||
| Pre-arrival batches with RP/QP release workflow | |||
| Lab results and CoA review | |||
| Deviations and CAPA | |||
| Licence portfolio with expiry alerts | |||
| Training matrix per role and SOP | |||
| AI label reading for product records | |||
| Import chain and inspection readiness | |||
| Import dossier — five-section assembly per shipment | |||
| BtM narcotics ledger and BfArM annual report | |||
| Relabeling and repackaging records | |||
| Logistics and packing lists | |||
| Regulatory calendar and intelligence feed | |||
| AI drafting: SOP generator, Annex generator, gap analysis | |||
| Account | |||
| Named user accounts | up to 5 | up to 25 | unlimited |
| Service level | Standard support | Guided support | Partner support |
Human service, written down
ComplyPharm is built and supported by a small team working with AI assistance. These commitments are what that team can genuinely hold — nothing beyond it is promised.
| Service level | Standard support | Guided support | Partner support |
|---|---|---|---|
| Response time | Human reply within 2 business days | Human reply within 1 business day | Human reply within 4 business hours |
| Onboarding | Written onboarding guide plus one 60-minute remote kick-off | Guided setup — up to three 60-minute sessions, including a document import walk-through | Guided setup with no session cap during the first 90 days |
| Periodic reviews | Release notes when the platform changes | Quarterly 60-minute review of configuration and open items | Monthly 60-minute review of configuration, evidence gaps and open items |
| Inspection and audit support | Not included | Written guidance on exporting evidence for an audit | Preparation session before a planned inspection or audit — up to two per year, booked at least 10 business days ahead |
| Contact channel | E-mail and scheduled video calls | E-mail, scheduled video calls and an agreed messaging channel | |
| Named contact | Shared support address | Named contact person | Named contact person |
What we do not promise
- Support hours are 09:00–17:00 Central European Time, Monday to Friday, excluding Polish public holidays. There is no 24/7 service.
- Response time means time to a human reply, not time to resolution.
- ComplyPharm is a software supplier. We do not certify, validate or audit your quality system, and we do not act as your Responsible Person or Qualified Person.
- Regulatory decisions, releases and submissions remain with your qualified people.