Dossier Preparation & Submission
Carefully-considered, well-written and comprehensive submission packages are a central factor in achieving regulatory approvals in a timeline manner. G&L has a wealth of experience in compiling, authoring and publishing regulatory submissions across all product types and markets, as well as liaising with, and submitting to all major regulatory agencies across the globe.
- Authoring of CTD Modules 1-5 (or equivalent)
- eCTD Publishing
- Local/Portal Submissions Contact Us to Learn More