This service covers following items. Local experts in our network help product registration.

Contact
  1. Regulatory
    • Set regulatory strategy
    • Assist PMDA* consultation
    • Prepare application form
    • Support application
  2. Reimbursement
    • Set reimbursement strategy
    • Prepare application form
    • Support application
  3. QMS
    • Consult to prepare QMS manuals, regulations, and procedures
    • Consult to prepare relevant documents
    • Commentary on QMS ministerial ordinances
  4. Clinical Trial
    • Protocol development
    • Medical writing
    • CRO management

*About PMDA
PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare.
Our obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
We conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety. We are also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.