Regulatory Affairs
End-to-end services to guide you to regulatory approval
Regulatory approval is the end goal, and success requires a partner who knows what works and is skilled in end-to-end regulatory services – from early strategy to new marketing applications and regulatory meetings.
As seasoned drug developers, we’ve been in your shoes, with an array of successful global marketing approval submissions.
- Regulatory and development strategy for the US
- Gap analysis and mitigation strategy
- Interactions with the US FDA across the development process
- Expertise in various submission processes for both the FDA
- Regulatory operational services and marketing applications, e.g., Pre-IND, IND, IND/CTA, NDA, BLA, etc.
- Regulatory and competitor intelligence service
Guided by experience at the FDA
D2V Clinical’s President and Regulatory Officer, Xianhua (Walt) Cao, Ph.D., guides our team informed by more than 20 years of experience in drug discovery and development in both the pharmaceutical industry and the U.S. Food and Drug Administration. During his tenure at the FDA, he worked extensively with:
- NME NDA/BLA applications and more than 500 IND Phase I-III clinical trial protocols
- Drug development and marketing application for both new chemical entities and new biological entities
