Assuring Regulatory Success with Customized Submission Support that Accelerates and Anticipates
Accelerate submission success with unrivaled expertise, advanced technology and round-the-clock operational flexibility.
Want to learn more about how we can help assure your regulatory success? Contact us today.
"Working with Synchrogenix was the next best thing to having a fully staffed and seasoned RegOps team on site." -Vice President, Regulatory Affairs | Gritstone Oncology
Anticipating Challenges Helps Accelerate Submissions & Mitigates Risk of Costly Delays
- Proactive management of project timelines
- Deep regulatory knowledge enables fast responses to changed regulatory requirements and mandates
- Proven track record in rare/orphan diseases and gene therapy
- Flexibility to meet changing requirements and timelines
- Simplified submission review
Synchrogenix supports sponsor submissions to all major global agencies.
- Investigational and marketing application submissions
- Lifecycle maintenance submissions
- Master file submissions
- Dossier management
- U.S. agent services
- Electronic transmission
- Regulatory affairs