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.

DOCUMENT MANAGEMENT SERVICES

•       Document Management consultancy
•        Bibliographic research in scientific databases and document delivery:

            –       Identify information needs

            –       Select information sources

            –       Build search strategies

            –       Document delivery

•        Email Alerts
•        Bibliographic management tools

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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