Regulatory Affairs

Preparation of IND/NDA Dossier that meets the high quality standards is one of our main specialties. Our regulatory affairs specialists with experiences in various global clinical trials and IND/NDA Dossier preparation and submission and our professional medical translators are ready to help you.
Furthermore, our favorable relationship with MFDS reviewers allows us to better identify the issues that the MFDS reviewers might have in mind and our feedback and consultation services will help our clients to save time and money.

Pre-clinical Test
Consulting

CMC
Consulting

Regulatory Strategy
Consulting
for IND/NDA

Bridging Study
Consulting

Pricing Negotiation
Consulting

Pre-clinical Test Consulting

CMC Consulting

Regulatory Strategy Consulting for IND/NDA

Bridging Study Consulting

Pricing Negotiation Consulting

Experience
Experience

Study Types

80 Projects

Therapeutic Area

80 Projects
[Updated on June 2017]