Regulatory affairs

Regulatory awareness is essential to Chempilots in order to facilitate R&D projects and custom medical productions for our medical device and pharmaceutical customers.

Chempilots offers to identify quick strategic paths and to support the customer in developing the appropriate tests and rationales.

Technical input
Chempilots can support a customer’s regulatory filing by describing and documenting new products and production processes. This may include:

Application for a CE mark according to the Medical Device Directive (MDD)
Support in planning processes and presentations at MDD/NB and FDA inspections
Technical documents for use in IDE and PMA applications - 510k
Technical input for new medicinal product applications (ICH guidelines)

Contact us
For more information please contact Richard Schmidt on
+45 4495 1661 or by e-mail.