Quality is key for the complex and demanding area we are in.
Our quality management system provides optimal quality assurance for the polymers and functional molecules that we develop and manufacture for our customers. The system is designed in compliance with the industry guidelines of the US and EU authorities to manufacture (polymer) intermediates for Active Pharmaceutical Ingredients (ICH Q7) and Medical Devices (21 CFR 820 / ISO 13485).
In 2022 we have been audited for a GMP license by the Dutch Health Inspectorate (IGJ) for analysis of pharmaceutically active polymers and drug products made thereof, with a positive outome.
For already more than 10 years our organization is ISO 13485 certified (since February 2010). We are one of the first biomaterials companies in the world with such certification, if not the first. This has driven us to continuously improve our organization with focus on performance and customer satisfaction and we keep doing this every day.