Professional Services

Regulatory affairs guidance

The basis for the evidence of safety and efficacy of a product lies in its specifications. Right from the beginning of the development phase, we support you with the compilation of the evidence and in the search of pragmatic solutions. The evidence together with the specifications form part of the product file, which can be audited by the Notified Bodies and authorities.

Our regulatory affairs guidance covers among others the following activities:

  • project coordination
  • preparation of requirement and functional specification documents in the planning phase
  • identification of the legal and normative requirements
  • to conduct and implement risk assessments
  • preparation of the necessary documents of evidence
  • development of concepts for testing, verification and validation
  • coordination of laboratory tests and product verification
  • support during product and process validation
  • support with the design and monitoring of studies, clinical and field trials
  • support, guidance and monitoring of conformity evaluation and registration procedures