Compliance is the
foundation, not the goal.
Every shipment leaving our warehouse passes through a documented quality system — from supplier qualification to batch release, from temperature monitoring to pharmacovigilance. We treat regulation as the floor, not the ceiling.
A documentation-first
quality framework.
Our quality system is built to be inspected at any time, by any regulator, in any of the 14 markets we serve. Documentation is structured, versioned, and retained for the full statutory period.
Eight layers of
control, end to end.
Every step of the supply chain — from goods receipt at the warehouse to delivery to the pharmacy — passes through a documented control point with an assigned quality owner.
Supplier qualification
Every manufacturer audited against EU GDP before contract signature. GDP certificate verified, GDP-related audit history reviewed.
Goods receipt & batch certification
Every inbound batch verified by our Qualified Person (QP) against manufacturer CoA, serialisation data, and packaging integrity.
Temperature-mapped storage
Continuous temperature monitoring in all zones — ambient (15–25°C), refrigerated (2–8°C), frozen (-20°C). Annual mapping studies.
Validated cold-chain transport
Qualified thermal packaging, GPS-tracked vehicles, validated reefer fleet. Real-time temperature telemetry on every shipment.
FMD serialisation & verification
Every pack decommissioned at the point of dispense. End-to-end traceability through EU NMVS and partner national systems.
Pharmacovigilance liaison
Dedicated PV team handling adverse-event reporting, product complaints and recall coordination across all markets.
Documented deviations & CAPA
Every deviation logged, root-cause-analysed and closed with a corrective & preventive action within 30 days.
Annual quality review
Full system review prepared for the MAH every year — trends, deviations, returns, recalls, customer complaints and KPIs.
Every inspection
is a checkpoint.
We publish a summary of recent regulatory inspections and certifications. Full audit reports are available to qualified manufacturer partners under NDA.
Need our quality
documentation?
Qualified manufacturer partners can request our Quality Manual, Site Master File, and most recent regulatory inspection reports under NDA.