EU & FDA GMP
All sites inspected and approved under EU GMP and US FDA regulations.
Quality
A medicine is only as good as the batch it came from
We manufacture what we discover, which means quality is not outsourced. One system covers ingredient, process, release and delivery.
ISO 9001 & 14001
Certified quality and environmental management across manufacturing.
Serialisation
Every pack traceable under EU FMD and DSCSA requirements.
Pharmacovigilance
24/7 global safety monitoring with signal review by our medical team.
From ingredient to patient
01
Incoming materials
Every active ingredient tested and released before use.
02
In-process control
Continuous monitoring of critical parameters during production.
03
Batch release
Qualified Person release against full analytical and documentation review.
04
Distribution
Validated cold chain and temperature monitoring to point of dispense.
