PROJECT INITIATION AND REALISATION
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