Compiling and publishing European compliant MAA submissions

Real Regulatory can manage and complete the entire MAA dossier building and submission process. We will work and advise on the best strategy for your submission in Europe either via National, Mutual Recognition, Decentralised or Centralised route. Whether you are developing an NCE biological or small molecule origin, a hybrid product, or simply expanding your market access for an already approved product, RRL has the expertise to support all European dossier preparation, from subject matter expert input through to submission and approval.

Services include:

  • Strategy for regulatory submission route in Europe
  • Gap analysis of third country submissions for suitability for Europe
  • Generation of CTD sections from original data source reports or conversion of other third country applications for submission in Europe
  • Authoring of all sections including quality, safety and efficacy sections
  • Building and finalising Module 1 application form and appendices
  • Provision of subject matter experts for completion of the overviews and summaries comprising Module 2
  • Finalisation and publishing of a complete hyperlinked and validated eCTD
  • Submission of the MAA to EMA via the e-submission gateway or national agencies via CESP platform or local applicable portal
  • Managing the MAA submission through assessment and resolution of the application
  • Management of required follow up, including national requirements wide

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