Advanced therapy medicinal products (ATMPs) constitute a heterogeneous group of innovative therapies encompassing gene therapy, somatic cell therapy, and tissue-engineered products. This promising class of biopharmaceuticals is being investigated as a treatment for diseases known as untreatable today, such as Alzheimer’s or Parkinson’s and poses specific regulatory, quality and clinical challenges.

After the establishment of Regulation (EC) No 1394/2007 by the European Medicines Agency and the associated Transplantation Law in Switzerland, several aspects have to be considered when bringing an ATMP to the market. Medidee’s scientific team is ready to support you throughout the approval process with the competent authority:

  • Quality considerations for ATMPs: Good Manufacturing Practice (GMP) requirements and QC strategies
  • Global strategic quality and regulatory considerations
  • Classification of combination and borderline products
  • Complex clinical study designs to validate performance and safety
  • Risk management evaluations regarding clinical use, quality, efficacy and safety