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…)