Regulatory Operations
- Dossier compilation – all modules (eCTD, NeeS (non-eCTD), ACTD, Country Specific format)
- Submission Management (Electronic, Paper, eCTD, NeeS) ANDA/NDA/IND/ Technical Files/ DMFs, ASMF)
- Labeling & Artwork Management
- CCDS | Clinical Trial Applications | SPL Submissions
- Regulatory Data and Document Management
- Health Authority Interactions
- Post Marketing/ approval activities
