Regulatory Affairs Department

We provide meticulous, consistent and prompt regulatory support, delivering significant value added for the success of our clients.

This is achieved through:

  • Deep knowledge and consolidated experience of regulatory management of EU and no-EU registration dossiers and/or electronic submission (eCTD)
  • Assessment and management of the variations of our customers registrations according to the different countries regulations.
  • Ongoing personnel training to ensure constant alignment with current regulations and with specific requirements defined by regulatory authorities (MHRA, TGA, FDA, AIFA, EMEA, ANVISA, PMDA, HEALTH CANADA…)

(see API list and relevant DMFs)