European countries comprising of 31 nations have their own national requirements, fees requirements, different language and many others, making the regulatory filings very complex. NUVO will help you sail through complex requirements with ease. We can help with following activities to write file and get approval of marketing authorization applications (MAA) :
Guidance in best procedure to adopt for filing a MAA
Dossier writing for MAA as per ICH in eCTD.
Submission MAA to European countries as per the schedule via National, MRP. DCP and CP.
Interaction with regulatory health agencies for procedural matters.
Booking slots for marketing authorization application for MRP and DCP.
Conversion of CTD or NeeS format to eCTD.
Summary writing for Module 2 :
Literature references for Module 4 and Module 5
Braille for MAA
Assistance in Assessment report interpretation and response for the same at various steps during the national, MRP and DCP.
SmPC: Preparation of harmonized summary of product characteristics in QRD Format as per
PIL: Preparation of Patient information leaflet with its mock ups. Coordinating for its readability testing as per EFPIA General Recommendations for Readability User Testing of Package Leaflets for Medicinal Products for Human Use and MHRA Guidance on the user testing of Patient Information Leaflets.