We think product risk and we are used to medical device standards, GMP, production processes and balancing capacity. When engaging AP we will increase your likelihood of reaching the ROI and your market introduction time slot, since we focus on what is critical.

We have the ability and experience to analyse and convert critical product requirements into a stringent URS with requirements that are possible to verify and test

AP services include:

  • Authoring of User Requirement Specification according to cGAMP specifying customer needs
  • Understand, specify product critical functions and production capacity needs
  • Contribution with a broad set of skills (automation, production, GMP, testing and validation)