- 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
- 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
- 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
- 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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