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.

R&D approach
Chempilots has gained know-how within regulatory affairs in R&D. When developing new biocompatible materials or a product portfolio, formulations and processing technologies may be selected and specified in ways that makes it less comprehensive to provide preclinical documentation.

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 process and make presentations at MDD/NB and FDA inspections
providing technical documents for use in IDE and PMA applications
providing technical input for a new medicinal product application (ICH guidelines)

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