Regulatory

Tosoh Bioscience is ready to support your regulatory needs through the following options:

Confidential Information Disclosure Agreement

Tosoh Bioscience recommends establishing a Confidential Information Disclosure Agreement (CIDA) in order to begin a more detailed discussion about our products used during the development of a validated HPLC assay or in preparation for a filing of a new drug with the regulatory agencies. To initiate a CIDA:

• For process scale resins contact your local Account Manager.

• For HPLC applications contact the technical service group at [email protected].
  

Regulatory Support Documents

Tosoh Bioscience maintains Regulatory Support Documents on most of our process scale media. The documents contain detailed information that describes quality control of our manufacturing process. In order to support your application for a new drug, please contact us if you would like a copy of the sections of the Regulatory Support Documents relevant to the resin being used through your Business Development Manager or at [email protected].

Tosoh Bioscience can only disclose Regulatory Support Documents when a valid CIDA is in place.

Safety Data Sheets (SDS)

If you need a SDS on one of our products, please visit our SDS page to download the most recent copy.