Compiling, hosting and maintenance of regulatory dossiers

• Compilation of electronic dossiers (eCTD, non-eCTD electronic submissions/NEES, eCTA, ASEAN, VNEES)
• Experienced with many submission types (including MAA's, Variations, reformat and ASMF, PMF) for both Chemical entities and Biologicals.
• Registration of Medical devices and Veterinary products
• Well-knowledged of regional administrative information and requirements for various regions, including EU EMA, EU National Competent Authorities, US FDA, Health Canada and Swissmedic.
• Assembly of paper dossiers and print files
• Coordination of direct dispatch to regulatory authorities 
• Archiving and storage of electronic documents and dossiers

Preparation of baseline (reformat) submissions

• Ensure the right level of granularity is applied. This optimizes re-use of documentation across multiple products, regions and formats and positively impacts your submission maintenance.
• Consolidate the existing dossier to a "current view" for the baseline submission
• Split, merge, redact and publish NTA/ CTD documents to (e)CTD ready documents in MS Word and/ or PDF format, whilst keeping track on the contents' orginal location to support review by our sponsor
• Design of product specific content plans containing the correct document naming attributes and eCTD metadata

Lean publishing of regulatory documents

• eCTD readiness of documents, including paper and scanned images
• Design and maintenance of MS Word document templates

Outsourcing services

• On-site and/ or remote publishers and project leads to provide support durings peaks in workload
  • Regulatory Operations Assistants
  • Regulatory Operations Managers
• Well known with various eDMS, document publishing- and eCTD tools (including Adobe Acrobat, Documentum, ISI Toolbox, eCTDmanager, eCTDXpress, Insight Publisher, Docubridge, Sharepoint).
• Design and maintanance of MS Word document templates
• Training and workshops in the field of Regulatory Operations and Lean Authoring, together with our sister Company eCTDconsultancy
• Development of SOPS and business processes supporting First time right creation of compliant submissions