From the early stages of non-clinical tests to IND applications, can Hamari undertake drug substance CMC parts consistently?
From the early stages of non-clinical tests to IND applications, Hamari will work with you through to and help with IND requests and applications. On top of our manufacturing process, data from drug substances’ physical properties is recorded, analyzed and validated. Both our Kunijima, Osaka and Yonezawa plants are cGMP certified. The Yonezawa factory is FDA approved. During meetings prior to IND, we will advise and cooperate working together with you, and will also assist with the CMC parts of IND applications. 8. What is the total capacity of the reactors? Please see the specialized equipment section. 9. Are beta-Lactams (penicilin/cephalosporine), argochemical, steroid, cytotoxic, pesticide or any other potent substance produced at your plant? No, they are not. Back to Top 10. Do you have a reaction specialty? Please see the Core Reactions section by clicking here. 11. Do you use any special equipment? Please see the Specialized Equipment page by clicking here. 12. Are you ISO14001
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- Will the DCC prepare investigational new drug (IND) applications for Specialized Center clinical studies or will the DCC provide advice with a Specialized Centers on how to prepare an IND application?
- From the early stages of non-clinical tests to IND applications, can Hamari undertake drug substance CMC parts consistently?
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