Through Atreiza Laboratorios, we register products and provide our clients with our name, legal address, pharmacovigilance system, and regulatory activity.
We facilitate the registration of products in the European territory acting as Marketing Authorisation Holders.
How does the registration process work?
Application for registration
Centralised
Mutual recognition
National
FDA
Support during the registration procedure
Initial application
Resolution of deficiencies
National phases
Support for the holder maintaining Marketing Authorisation
Variations
Splitting texts and Readability Test
Ownership Transfers
5-year Revalidation
Annual marketing maintenance
Temporary suspension/revocation
Other communications in Applications to the Spanish Agency of Medicines and Medical Devices (AEMPS)
