Regulatory Support

Regulatory Support 

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 [email protected] to initate a CIDA for your HPLC applications.

Tosoh Bioscience maintains Regulatory Support Files (RSF) on most of our process scale media. The 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 [email protected] if you would like a copy of the sections of the RSF relevant to the resin being used. Tosoh Bioscience does not disclose this information unless a valid CIDA is established first.