After CP, DCP/MRP Procedures, and according to the eSubmissions Roadmap Timelines, eCTD format is now mandatory for all National Procedures in Europe CP Procedure -> eCTD Mandatory from 2010 DCP / MRP Procedures -> eCTD Mandatory from January 2018 NP…

MHRA has sent to Marketing Authorization Holder (MAH) a guidance outlining requirements for submitting baseline information on your product in case of Brexit No Deal Scenario . As MAH, you should be prepared, and BlueReg can provide regulatory and publishing…