Type II Master Files (for a Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product) for CryoStor® and HypoThermosol® are currently filed with the United States Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER).
If you intend to incorporate our products as ancillary or excipient reagents used in the manufacture, storing, shipping, freezing, and/or infusion/injection of cell and tissue based products or therapies, and are submitting an application for approval of a clinical trial to the United States FDA, please complete the form below.
You may request a cross-reference to our Master Files only if you intend to submit an investigational new drug (IND) application to the United States FDA. After verification of your request, we will generate an authorization letter for your files and notify the FDA of your request.
For support and documentation for using our products in clinical trials submitted to regulatory agencies outside the USA, please contact firstname.lastname@example.org.
Our Master Files contain proprietary information and are not available for disclosure directly to customers.