OP Pharma offers a complete and structured service for managing regulatory procedures, technical documentation, and strategic consultancy.
Since 1996, alongside pharmaceutical companies.
Updating and management of documentation. Archiving, submission, and secure sharing of eCTD sequences with e-Dox.
Complete management of Marketing Authorization (MA) applications, variations, and renewals through national and European procedures. Continuous digital support with the e-Reg platform.
AIFA and Italian Ministry of Health Power. Specialist intermediation, definition of the regulatory strategy and problem solving with the competent authorities.