eCTD Readiness
- Interview regulatory and publishing staff and develop user requirements
- Review internal processes for document preparation and approval
- Examine granularity of prepared documents and map to eCTD requirements
- Review adequacy of IT infrastructure to support transition to eCTD
- For US submissions – guidance regarding SPL/PLR creation and maintenance
- For EU submissions – guidance regarding PIM creation and maintenance
- Map regulatory document repository in EDMS to eCTD publishing environment
IT Architecture
- If needed - create technical design specifications for an IT architecture to support eSubmissions
Implementation and training
- Provide training and end user support utilizing my experience with various tools for EDMS, publishing, eCTD building/viewing/validating
- Project management to oversee configuration, installation, validation and training
- SPL/PLR support – oversee outsourcing of legacy conversion and/or tool implementation
Submission Preparation
- Provide expertise on-site or remotely as required to assist with submission preparation, including:
- Regulatory requirements for document formatting
- Templates
- Best practices
- SOPs
- Liaise with FDA eSubmission staff from pre-NDA meeting to actual submission
eCTD Maintenance
- eCTD and SPL/PLR lifecycle management support
- Support for responses to requests from FDA reviewers