Meeting timelines. Meeting needs.
PharOS develops and applies Regulatory Affairs Strategies which enable you to ensure that your product is launched on day 1 after patent expiry.
Through our planning and strategizing we can guide you through, from the design of your Regulatory application right through to approval our experienced team of professionals from various scientific backgrounds will advise you every step of the way.
In order to answer demanding national regulatory requirements, PharOS cooperates with EuDRAcon®, a pan-European network of regulatory consultants. Our partnerships with companies, who are experts in their national regulatory systems, allow us to manage MRPs/DCPs as well as national applications across EU at the most effective way.

Which Regulatory Services can we offer you?

• Marketing Authorization applications through MRP/DCP and national procedures
• Preparation and submission of Greek incoming MRP/DCP applications including trademark registration and on-site validation of the application
• eCTD preparation
• Post-marketing applications (variations and renewals)
• Pharmacovigilance