What we do
- Deviation management
- Deviation investigations
- CAPA tracking
- Gap register
- Supplier scorecards
- QA review of incoming consignments
- Document management support
- Staff training
How it runs
- 01
Opening Assessment
We take stock of open deviations, CAPA and gaps, so we both know where the work starts.
- 02
Scope & Retainer
We agree in writing what we handle each month and what stays with you.
- 03
Monthly Work
We investigate deviations, track CAPA and review each incoming consignment.
- 04
Registers
We keep the deviation register, the CAPA tracker, the gap register and the supplier scorecards current, ready for an inspector.
Other services
- Importing flower or extracts into the EUEU GMP supplier qualification
- Auditing a supplier, a CMO or your own siteIndependent EU GMP and GDP audits
- Growing cannabis for medical useGACP cultivation compliance
- Selling to EU GMP buyersFrom GACP to EU GMP
- Building or fixing your quality systemPharmaceutical Quality System
- Training your people on GMP, GACP or GDPTraining
Read more
- Why do clients ask us whether we do everything?A pharmaceutical distributor we met in Berlin asked us for audits, then for software, then for a new brand, and this story shows how we work.Read the article
- First-party or second-party audit: which one do you need?One looks inward at your own quality system, the other looks outward at your suppliers. EU GMP expects both, and neither can stand in for the other.Read the article
