Main Menue


    PPG inc.

    973-11 Hongo-cho, Kita-ku, Saitama city, Saitama, Japan 331-0802
    TEL +81-48-676-0774



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?