Chempilots can assist you establish dedicated quality systems 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 systems
Chempilots develops innovative processes that can be validated. We also offer dedicated quality systems that reflect customerís 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 Q7(active pharmaceutical ingredients).
> Regulatory affairs
Chempilots can assist customers in providing technical input for regulatory files and developing the appropriate tests and rationales.
For more information please contact Richard Schmidt on +45 4495 1661 or by e-mail.