Symyoo provides the unmatched regulatory expertise you need with established regulatory partnerships in the world your trials operate.
Our Regulatory Science team’s end-to-end expertise provides a blueprint to the successful MFDS/FDA/EMA approval for your drug, biologic and medical device development.
In addition to providing the regulatory strategic recommendations and guidelines, Symyoo’s RS team acts as a liaison between the IRB, Regulatory Authorities (MFDS/FDA/EMA), customers and partners, while ensuring all regulatory documents are in compliance with applicable regulations, ICH/GCP guidelines, and many applicable policies and standards.
- Gap analysis
- Regulatory filing (IND: Investigational New Drug) and follow-up
- Evaluating the best regulatory path (Fast track, Breakthrough therapy , Accelerated approval, Priority review, Orphan drug designation) for applications
- Regulatory meeting support and representation