Select Page

Product Registration, Manufacturing and Product Life on the Market

Given the complexity of the legal issues associated with the marketing of medicinal products and medical devices, we support our clients with our knowledge and practical experience to enable the most effective marketing of such products and devices. We assist our clients in selecting the optimum registration procedure and in designing all aspects of the products’ life on the market.

We provide the following services:

  • Legal assistance in preparing registration dossiers and the relevant notifications, and representation in procedures for obtaining administrative decisions related to the marketing of medicinal products and medical devices
  • Advice on product quality and safety supervision, in particular in the field of pharmacovigilance, including assistance in developing operational procedures, day-to-day assistance, periodic training of staff on procedures, preparation for audits/ inspections and representation in pharmacovigilance procedures
  • Advice on withdrawal of products from the market
  • Legal advice on contract manufacturing of medicinal products, including drafting, reviewing and verifying related agreements;
  • Representation before regulatory authorities, including active support in various inspections