Combination products

I have hands-on experience with the following tasks for various kinds of drug/device combination products, incl. prefilled syringes, autoinjectors, transdermal patches and implants:

  • Regulatory strategies for startups and/or new products.
  • Device related development: usability/human factor testing, writing CER – clinical evaluation, verification and validation.
  • Writing regulatory applications: clinical trail applications and market applications.