Regulatory Documentation with e-Publishing
The Aptiv Solutions global e-Publishing team will assemble, review, publish and manage Sponsor regulatory documentation, taking advantage of advanced and widely accepted submissions management tool (docubridge®). Aptiv Solutions publishing team has significant experience with European and US regulatory agencies covering all forms of regulatory submission.
Regulatory Documentation Expertise Includes:
- Documentation clean up and formatting
- eCTD publishing
- Non eCTD Electronic Submissions (NEES) and paper submissions
- Comprehensive dossier life cycle management