Having been approved as an official Marketing Authorization Holder (MAH), IDA is able to file and maintain official submissions to MHLW on behalf of IDA clients.
- Filing and maintaining Japanese New Drug Applications (J-NDA)
- Filing and maintaining Orphan Drug Designation Applications (ODD)
- Submit applications for and receive subsidies from National Institute for Biotechnology Innovation (NIBIO)
- Conduct GMP audits at local and overseas manufacturing sites
- Obtain approval and maintain of National Health Insurance (NHI) drug pricing
- Management of mandatory Post-Marketing Surveillance (PMS) programs
- Manage product lifecycle, including obtaining approvals for new indications