The Quality Management System has been designed and implemented to fulfil the following basic objectives:
The main commitment of our policy is to achieve and maintain the trust and satisfaction of our customers through the supply of best quality products.
Our facilities are regularly inspected by Health Authorities (European Authorities, FDA, PMDA…) and customers. We have more than 20 years experience with a very good inspections results.
FDA (US) Inspections: 6 FDA Inspections from 1999 to 2017, the last 4 without 483 observations.
PMDA (Japan): 9 Off site inspections.
AEMPS / Generalitat de Catalunya (Spain): 3 inspections, last one in May 2018. No major observation. GMP Certificate valid until May 2022.
Our analytical departments support the whole product lifecycle. Our capabilities are the following:
Our laboratories are equipped with the following main instrumentation:
Our Regulatory Affairs team has an important role in any project during all the lifecycle, in order to prepare and deliver the necessary registration documentation for the intermediates and APIs for submission to the regulatory authorities (US Food and Drug Administration (FDA), European Medicines Agency (EMA), European Directorate for the Quality of Medicines (EDQM), Japan PMDA, China FDA (CFDA)…)
We prepare and deliver the necessary registered documentation for active pharmaceuticals ingredients (APIs) and intermediates for submission according to the guidelines: