Gerresheimer Services

Regulatory Affairs Services

Services during the development and registration phase of medical devices.

Managing regulatory risks

  • Flag, mitigate, define fallback options
  • De-risking activities may include pre-registration interactions with, e.g., FDA and notified body

    Decrease certain business risks

Medical device documentation

  • Preparation of RA deliverables
    (e.g., definition applicable regulatory and normative requirements, classification)
  • Review of the device documentation
  • Technical writing

    Ensure smooth registration process

Regulatory submissions

  • Definition of regulatory strategy
  • Pre-submission meetings with FDA (incl. preparation of briefing package, meeting materials and meeting minutes, as well as conduct of meeting)
  • Preparation and submission of regulatory submission files
  • Management of deficiency reports

    Obtain regulatory approval

Contact us!

Regulatory Affairs
Elly Gysels, (PhD)
Head Regulatory Affairs
Phone: +41 622 097 106
E-Mail: Elly Gysels