Pharmaceutical Applications
Sumika Chemical Analysis Service offers a range of support services for work related to pharmaceutical applications. We cover everything from consulting on testing to preparing application documents. Please contact us for details.
- Consulting on development/application for pharmaceutical products/medical devices
- Gap analysis between overseas application data and domestic application
- Consulting on application strategies
- Support for consulting with regulatory authorities (such as PMDA)
- Other items related to pharmaceutical product regulations
- Applications for manufacturing and sales approval
- Support for preparing CTDs and other application materials
- Review/QC for application materials
- Support for matters of inquiry from regulatory authority
Registration / Management of Overseas Drug Master Files (DMF)
- Preparation support and registration for DMF registration materials
- Maintenance/management of registered DMFs
- Other related procedures
Contact Us for Services
For inquiries and requests concerning services of analysis, measurements, products and consulting, please contact us via inquiry form.