Borderline Products

Are you trying to comprehend the maze of regulations to determine if your product is to be considered a Medicinal Product, a Medical Device, an ATMP or a Biologic? Do you get conflicting input from regulatory bodies in different countries?

Having dealt with a large number of borderline products we can support you to get the right answers from the right regulators that will allow you to pursue the development of your drug without late surprises or unexpected hurdles.

We can support you with

  • The classification of Medical Devices
  • Getting agreement with authorities for borderline products
  • Determine whether your product is considered an ATMP in the EU.