Regulatory Support
- Regulatory strategy development: We develop regulatory strategies and prepare dossiers for global submissions, ensuring compliance with FDA, EMA, and other agencies.
- Dossier preparation and submission support: Our experts guide clients through Chemistry, Manufacturing, and Controls (CMC) documentation and approval processes.
- Guidance for global regulatory approvals: We offer end-to-end support, from strategy development to post-approval change management.
Our Services
Vellagen offers a comprehensive and customised suite of services to meet the diverse needs of the pharmaceutical industry.
