European countries comprising of 27 European union (EU) nations and UK 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) :

NUVO provides efficient solutions to making quality Marketing Authorisation Application (MAA) submissions for entire Europe to support the filing and approval procedures. We guide with complete process and documentation required for the safe filing, review and approval of the MAA.

European filing procedures:

  • National Procedure
  • MRP – Mutual Recognition Procedure
  • RUP – Repeat MRP
  • DCP – Decentralized Procedure

Following are the brief listing of the activities and services provided by NUVO :

  • Dossier Due diligence
  • Dossier audit
  • Dossier conversion from CTD/NeeS to eCTD
  • Dossier module writing for MAA as per ICH :
    • Module 1 – Administrative
    • Module 2 – Overview and Summaries
      • Quality
      • Non-Clinical
      • Clinical
    • Module 3
    • Module 4
    • Module 5
  • Dossier for MAA publishing in eCTD for various procedures like National, MRP, RUP, DCP and Submission by CESP
  • Query response assistance while review when referenced to MAA application
  • Assistance in response to request for additional information
  • Support and assistance to overcome validation issues if any.
  • Guidance in best procedure to adopt for filing a Marketing Authorisation Application (MAA)
  • Submission MAA to European countries as per the schedule via National, MRP. DCP and CP and managing the complete procedure until approval and further life cycle managemnet assistance.
  • 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.
  • Assistance in Assessment report interpretation and response for the same at various steps during the national, MRP and DCP.
  • EU Marketing Authorisations – Legal basis and dossier and requirements assistance
  • Support in understanding and interpretation of Regulation (EC) No. 1234/2008, Directive 2001/83/EC and scientific guidelines
  • End to end Support in filing the MAA for
    • Article 8(3) Full or full-mixed application (complete dossier)
    • Article 10(1) Generic medicinal product application
    • 10(3) Hybrid medicinal product application
    • 10(4) Similar biologic product application
    • 10a Well established use application (literature only)
    • 10b Fixed dose combination (components already authorised separately) application
    • 10c Informed consent application
    • Line extension applications

eCTD Publishing services :

  • eCTD Compilation, QC Review, Technical Validation and Submission Hosting
  • eCTD Lifecycle Management
  • Baseline eCTD : Dossier conversion from Paper/CTD/NeeS to eCTD.
  • Importing and Cloning of Existing eCTD Applications
  • eCTD publishing for MAA Dossier
  • Complete validation support
  • Query response for request for additional information
  • Assistance in OCR (Optical Character Recognition), Embed Fonts, Compliant with Regulatory Requirements
  • Assistance in setting up PDF attributes
  • Assistance in hyperlinking
  • Pdf publishing: PDF – Ready for Submission, Bookmarking, Hyperlinking,

MAA Submission and Proccedure Managment Services:

  • We assist in MAA submission to European health authorities via its submission portal CESP.
  • All the above mentioned eCTD published MAA in original, along with changes and query response. LCM variation can be submitted by us to European Health authority.
  • Complete procedure management for the product via National/MRP/DCP
    • Procedure and submission strategy
    • Deciding on Reference Member state (RMS) and Concerned Member State (CMS)
    • DCP/MRP Slot application
    • Submisison
    • Validation
    • Clock stops
    • Query response assistance during clock stops.
    • National Phase and labeling assistance.

Life-cycle management of Marketing Authorisation Application (MAA) : 

  • MAA revisions preparations, eCTD publishing and filing with US FDA
  • Query response to support the amendment filing to safe approval
  • Grouping of Variations and worksharing for faster approval.
  • Life cycle Management complete activities form its preparation, pubihsing and submission:
    • Query responses,
    • Renewals,
    • Variations
      • Type – I
        • Type – IAIN
        • Type – IA
        • Type – IB
      • Type – II

European Support services for MAA preparration and Filing :

  • Selection and Sourcing of RLD for product development
  • European market entry strategy with BD
  • Module 2 writing for Clinical and Non-Clinical Overviews and Summaries
  • Literature references for Module 4 and Module 5
  • SmPC – Summary of Product Characteristics Preparation and harmonization of SmPC in QRD Format
  • PIL – Product Information Leaflet – Preparation of PIL with its mock ups. 
  • User testing of PIL (Readability studies) – 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.
  • Translations for SmPC, PIL and  labeling
  • Braille for MAA
  • Local representative in EU.
  • PSUR Writing

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