Regulatory Services
Working together, our regulatory consulting services empower you to maintain control of your pathway and stay ahead of any compliance risks. With practical interpretation, we help you understand how guidelines around the world apply to you – including in expanding markets.
Regulatory Services Detail
- End to end Regulatory Strategy and submission
- eCTD & SPL
- DMF Management
- Dossier Preparation & Submission
- Life Cycle Management
- Regulatory Support Services
- ANDAs dossiers preparation and submission
- MSDS
- PDE/OEL reports in accordance to EU guideline.
