Services

Regulatory Affairs

  •        Outsourcing: creation and maintenance of the registration dossiers. Compilation and development of:

             -         Dossier modules: administrative, overall summaries, quality, preclinical and clinical

             -         Post-authorization activities: modifications, PSURs and renewals

             -         Consultancy in terms of the new variation regulation concepts: grouping, worksharing

             -         European Drug Master File (EDMF)

  •        Non-prescription switching (Rx to OTC switch)
  •        Overall summaries and overviews writing
  •        SmPC, PIL and labelling
  •        Risk Management Plans
  •        Consultation with Target Patient Groups
  •      eSubmission: eCTD/NeeS compilation and assessment


eSUBMISSIONs

  •        Assessment during the design of the compilation
  •        Compliancy with the format specifications.  
  •        Creation of baselines (conversion from CTD/NEES to eCTD)
  •        Support for preparing the submission: documents’ granularity and settings, hyperlinks and bookmarks, security options, etc.
  •        Submission outsourcing and hosting
  •        Lifecycle management
  •        Training
  •        Software distribution. InvoFarma is the LORENZ Life Sciences distributor in Southern Europe and Latin America.


TRANSLATION SERVICES

  •         InvoFarma translates technical documentation from and to the following languages:

English, French, Italian, Portuguese, German, Spanish and others

  •         Translations are performed by a team of experts in Regulatory Affairs.

 

 

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