We guide you through all stages of development and application, taking the lead for the entire project or forming part of the team for single tasks.

Scientific Services

  • quality, non-clinical and clinical expertise
  • evaluation of existing documentation, gap analysis, development plan for new products and in life cycle
  • dossier compilation: Briefing Document (for Scientific Advice),
    IMPD (for Clinical Trial Application), CTD/ e-CTD (for Marketing Authorisation Application)
  • dossier amendment: Variation Package
  • participation in Scientific Advice Meetings
  • expert statements, summaries/ overviews (e.g. CTD Module 2)
  • consolidation of dossiers: identification of valid dossier sections from archives containing many variations

Regulatory Services

  • compilation of application dossiers, submission,
    procedure management
  • Agency communication, follow-up
  • Scientific Advice SA, Clinical Trial Application CTA, Marketing Authorisation Application MAA (NP, DCP, MRP)
  • compilation of Baseline Dossiers
  • Variations, life cycle, regulatory compliance

Project Management

  • monitoring of progress in development projects
  • co-ordination of activities (internal and external resources) including manufacturing sites, laboratory work, CRO and experts involved
  • co-ordination of e-CTD initiative, baseline compilation and variation packages
  • organisation of team meetings and report to management