PRE-SUBMISSION

As part of the development support, we also assist our clients in all matters ranging from administrative all the way to complex scientific authoring for submission purposes. Additionally, all requirements, depending on the regions are advised upon well in-advance of a submission planning. Our team members were working in various roles in Agency and remain updated with regards to current and upcoming requirements, which is critical for submission planning.

Some of the services offered in this area are:

• Strategic planning for MA submission - local and global
• Authoring of Documentation for all Modules for CTD format
• Consolidation of regulatory requirements per region to current standards
• Gap Analysis and Dossier Compliance
• Technical documentation preparation - ERA, RMP, overviews, summaries
• Pre-auditing and prepare for GMP Inspection
• Batch release and testing documentation
• Local language requirements, documents and supports
• Finalisation and review of full submission dossier
• Publishing eCTD and versioning
• Support for labelling and packaging material
• Translations

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