US FDA Master File Cross Reference Request Form

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 us via our Ask the Scientist page.

Our Master Files contain proprietary information and are not available for disclosure directly to customers.

Thank You,

BioLife Solutions, Inc.

Customer Service Team





    Zip/Postal Code*



    Contact/Principal Investigator Name*

    Contact/PI Phone*

    Contact/PI Email*

    Full IND Name*

    Full IND Number (or TBD if not assigned)*

    Full NCT Name*

    Full NCT Number (or TBD if not assigned)*

    Volume of BioLife Solutions Media utilized per cell product (mL)*

    What Stage of Clinical Trial is Your Organization at?*

    BioLife Product*

    Product Intended Use*

    Route of Administration*

    *indicates required fields

    This form collects your submitted data so that we can respond to your request. We may also occasionally contact you with updates about BioLife Solutions products and services. We respect your privacy; you may opt out of our contact list or update your contact preferences at any time. Please review our most recent Privacy Policy for details about how we manage and protect your data.

    BioLife Solutions Inc.

    3303 Monte Villa Parkway,
    Suite 310, Bothell, WA 98021
    Telephone: +1.866.424.6543
    or 425.402.1400
    FAX: +1.425.402.1433