1. Working together with clients to build regulatory development strategy
There are many guidelines and notifications on clinical development and practice issued by Japan regulator, to build regulatory strategy needs to understand the meaning of them accurately by experts.
2. Preparing and submitting high quality regulatory documents, including PMDA consultation package, Clinical Trial Notification(CTN) package, etc.
Quality of Japanese regulatory documents, same with another regulator, are essential to get agreement with PMDA on the strategy.
3. Working seamlessly with clients so to facilitate PMDA consultation Process
Consultation process is a race against time, in short period many questions from the regulator must be returned with excelleuts translation quality.
4. Acting as clients’ local regulatory representative during the entire process dealing with regulatory authorities
Use of well experienced staff for consultation process is essential for working as a representative.
5. Utilizing our experience and expertise to establish and implement
Only experts should work the regulatory strategy.