Certifications

Our quality credentials, independently verified.

Standard 01GMP AlignedEMA-aligned manufacturing protocols.

Standard 02ISO/IEC 17025Calibrated analytical instrumentation.

Standard 03COA Per BatchFull Certificate of Analysis on every shipment.

Standard 04HPLC VerifiedPurity profiling on every production lot.

01 — Manufacturing

GMP-aligned production, audited regularly.

Norven Medical GmbH operates in alignment with GMP (Good Manufacturing Practice) guidelines as defined by the European Medicines Agency (EMA). Our Frankfurt production facility undergoes regular internal audits and third-party inspections to maintain compliance with EU pharmaceutical standards.

02 — Analytical

Instrumentation calibrated to ISO/IEC 17025.

All analytical equipment used in our quality control laboratory is calibrated and certified in accordance with ISO/IEC 17025 standards. Our HPLC systems, mass spectrometers, and lyophilisers are maintained under documented service protocols.

03 — Certificate of Analysis

A signed COA accompanies every shipment.

Every batch shipped by Norven Medical includes a Certificate of Analysis containing:

Compound name and batch number
Synthesis date and expiry date
HPLC purity result (%)
Analytical method used
Authorised signatory

COAs are available for download on our order tracking page.

04 — Data Integrity

Full chain-of-custody, retained for five years.

We maintain a full chain-of-custody for all raw materials and finished compounds. Documentation is stored securely for a minimum of 5 years and is available to institutional clients upon request.