At Shiono Finesse, our six departments (or “Project Teams”)
work together in cooperation to progressively try new things and meet new challenges.
We endeavor to create an environment where we can utilize the ability and expertise of each and every employee.
Shiono Finesse offers contract manufacturing services of API and related services including custom synthesis, R&D, and analytical services.
High quality services we render are supported by advanced technology and a fully implemented quality assurance system.
- Contract Manufacturing
・Process Development and Manufacturing
- APIs and Intermediates for APIs
- Investigational Drug Substances and Intermediates
Pre-clinical Development〜Clinical Development Phase I to III〜Approved
Global GMP・Process Development
Analytical Testing・Analytical Methods Development・Stability Testing
GMP Documents・CMC Documents
Initial Inquiry to Fulfillment Process
Upon receiving a customer inquiry, throughout each step in the process until the final meeting after completion of production, we strive to respond quickly, always keeping in mind the aim of maximizing our customer’s satisfaction.
- Your inquiry/request can be made by e-mail/phone/ or discussion meeting.
- Our response to the inquiry/request will be made within two business days.
- non-Disclosure Agreement
- A non-Disclosure agreement will be signed and strictly followed.
- Manufacturing Details
- Further discussion on technology transfer, production scheduling, and other details.
- Cost Estimate <1-2 weeks>
- An estimate for the manufacturing costs will be provided within one to two weeks.
- Lab-scale Development <1-3 Months>
- ・Developments on the manufacturing procedures disclosed are studied at laboratory scale
・Based on our expertise, further development of the manufacturing processes is studied, as needed
・Progress report will be given, weekly or as needed, by e-mail/phone/TV conference/ or meeting.
- Pilot-scale Production <1-2 Months>
- A prototype Master Manufacturing Batch Record will be created according to the lab-scale studies, and pilot production will be made to set production requirements. Customers are encouraged to audit the production site and witness the pilot production. Sampling is also available.
- QA system/Delivery
- Production is according to GMP and the production site is inspected by the FDA. QA system is compliant to cGMP. Finished products are released with documents (COA, TSE certificate, etc.) to a designated delivery point.
- Post-manufacturing Meetings/Audits
- Discussion on the overall results of the production and the consideration of future manufacturing will be held.
Audits on documentation is available upon request.
- Commercial-scale Production
- Master Manufacturing Batch Record is completed according to pilot production records, and commercial (validation) production will be performed.