Quality/regulatory expertise

Developing new materials, defining innovative processes and running custom productions are our core competences. And because our customers are within regulated industries, we emphasize including appropriate solutions that will meet quality and regulatory requirements and/or requirements from environmental bodies. Thereby, the individual customer will have an integrated and holistic solution that can be readily implemented.  

Our competences related to regulated areas include:

> Quality assurance (QA)
Chempilots develops innovative processes that can be validated. We also offer dedicated quality systems that reflect customer’s stage of R&D and characterized by being flexible, economical and time effective, and which may comply formally with ISO 13485, FDA 21 CFR 820 (medical devices) or ICH Q7A (active pharmaceutical ingredients).

> Regulatory affairs (RA)
When developing new biocompatible materials and products we can assist our customers in identifying appropriate strategic paths that will minimize pre-clinical documentation. Furthermore, we provide technical input for regulatory files.

> Environmental affairs (EA)
When developing new materials and technologies we aim at minimizing environmental impact and waste management. This will also allow for a quicker permission to establish new production with any chemistry. We provide technical input for production permit, materials registration, and operational safety.

Contact us
For more information please contact Richard Schmidt on +45 44 39 61 15 or Paul Jansen on +45 44 39 61 14 (9-17 CET) or by e-mail.