Services
The PPG will support for your business as one of project members.
PPG will cover all life science area (Description Drug, Generic Drug, OTC Drug, Medical Devices, Re-generative medicine products and so on).
| Development regulatory | ・GAP Analysis ・Development Strategy ・PMDA Consultation Meeting ・NDA, eCTD submission ・Inquiries and Answer on PMDA review Phase ・and so on |
| IT implementation (ER/ES adaption) |
Implementation projects of ・eCTD Submission system ・Document Management System ・Electronic Signature ・and so on |
| ER/ES, CFR Part11 | ・adaption of Japan ER/ES ・CSV ・System assessment ・Vender Audit ・and so on |
| PMS | ・Crisis and Risk Management consultation ・Build up for Crisis and Risk Management organization ・Build up for Post marketing monitoring ・and so on |
| Medical Writing | ・Product leaflet ・Interview form ・and so on |
| Training | ・Training for new comer ・Training for mid-carrier ・Trainer of company seminar ・and so on |
For detail information, could you please contact us?