During the development of a validated HPLC assay or in preparation for a filing of a new drug with the regulatory agencies it may be advisable to initiate a more detailed discussion about Tosoh Bioscience's products. Tosoh Bioscience recommends establishing a Confidential Information Disclosure Agreement (CIDA). Please contact your local Business Development Manager regarding process scale resins or the technical service group at techsupport.sep@tosoh.com to initate a CIDA for your HPLC applications.
Tosoh Bioscience maintains a Drug Master File on most of our process scale media. The master file contains detailed information that describes the synthesis and quality control of our manufacturing process. In order to support your application for a new drug, please contact us through your Business Development Manager or at techsupport.sep@tosoh.com if you would like a copy of the sections of the DMF relavant to the resin being used. Tosoh Bioscience does not disclose this information unless a valid CIDA is established first.
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