Quality & Compliance
Registered, certified, and documented — with a quality system built to support your regulatory obligations as well as ours.
FDA registered
Registered with the U.S. Food and Drug Administration.
GHA certified
Certified by the German Health Authority for product bound for European markets.
cGMP compliant
Current Good Manufacturing Practice across storage and handling operations.
GDP compliant
Good Distribution Practice aligned operations across the distribution chain.
The quality system
Documented, trained, and auditable
A compliance claim is only as good as the records behind it. We maintain documented SOPs, a trained team, and a quality management system designed to withstand customer and authority audits — and to support the regulatory obligations our customers carry themselves.
- Robust quality management program with a specialty-trained team
- Documented SOPs across storage, handling, and transport
- Full chain-of-custody documentation and audit trail
- Validated equipment with scheduled requalification
- Deviation, CAPA, and change control processes
- Excursion containment, investigation, and reporting under SOP
- Quality agreement executed alongside the master service agreement
On excursions
Every temperature zone and every trailer is monitored continuously and independently. When a setpoint is exceeded, an alarm and a notification call are triggered, containment begins immediately, and the event is investigated and reported under SOP to your quality contact.
Need documentation for a qualification package?
Tell us what your quality team needs and we'll send it.