US-FDA Inspection

We are glad to announce that QualiMetrix has been successfully inspected by the US-FDA in the frame of a Pre-Approval Inspection in April 2019.

The inspection confirmed the site to be compliant with the principles and requirements of current Good Manufacturing Practices (cGMPs) under the United States regulatory framework (21 CFR Part 210 and Part 211) and more importantly, verified the adherence to our commitment to maintain the highest quality standards in order to ensure the quality of the medicinal products and patient safety.

This achievement sets an important milestone in our mission to support our customers’ submissions around the globe by providing services meeting the most demanding scientific and compliance requirements.

FEI No: 3015131309

DUNS No.: 363325610

Quality

EU GMP Certificate of Compliance
EU GMP Certificate of Compliance
FDA Registration

Relevant Services

Validation of analytical methods
Leachables and Extractables
 Elemental impurities (ICH Q3D)
Filter validation studies

QC Testing

 Skin permeation studies
Reverse engineering
Batch testing of APIs/final products/packaging materials
Stability studies