Clinical Development and Regulatory Affairs Consultation
Total Support for Development of Pharmaceuticals and Regenerative Medical Products
We provide consultation and support for pharmaceutical affairs at various stages, from the early stages of the development of pharmaceuticals and regenerative medical products to the implementation of clinical trials and approval applications.
We also provide services as an In-Country Clinical Caretaker for overseas companies that do not have a base in Japan.
We support not only clinical trials but the entire development process as well, from the initial planning stage to the submission for approval. We also respond to requests from sponsors to establish clinical trial implementation systems.
Staff with experience in pharmaceutical affairs provide reliable support in pharmaceuticals and regenerative medical products approval applications.
Compliance With the Latest Regulations
We continuously update the information on Clinical Development and Regulatory Affairs ensuring that our services meet the latest regulatory requirements.
Our Clinical Development and Regulatory Affairs Consulting Services provide detailed support for the following:
Clinical Development and Regulatory Affairs
- Clinical Trials Registration and Clinical Trial Notification submission support.
- CTD (Common Technical Document) creation and consultation regarding the application process for marketing.
- eCTD (Electronic Common Technical Document) compilation, submission of electronic data, and compliance with regulations related to digitization.
- Consultation regarding the sponsor`s clinical trial implementation system.
- Support for regulatory procedures (drugs manufacturing license, API Registration, foreign manufacturer certification, etc.).
In-Country Clinical Caretaker
We act as an In-Country Clinical Caretaker (ICCC) for overseas sponsors. When acting as an ICCC, we conduct all procedures with regulatory authorities (Clinical Trial Notifications, Safety Reports, Compliance Documents Investigation, GCP on site investigation, etc.) in the sponsor’s behalf.