Clinical Supply Regulation Resources

  1. Highly Potent, Perfectly Packaged 1/12/2023

    Experts explore a project to add a contained manufacturing facility and potent packaging suite by discussing the attention to technical detail required to exceed the required high standards and regulatory controls.

  2. Decentralized Clinical Trials: A Win For Patients, Sponsors, & Investigators

    Learn how the integral role of Direct-to-Patient Services plays a part in the execution of decentralized trials and how sponsors can maximize these benefits to improve drug development.

  3. The RMAT Designation: What It Means To The Advanced Therapy Supply Chain

    The RMAT designation gives the sponsor of a new drug access to increased meeting opportunities with FDA, in a manner comparable to those offered to sponsors of breakthrough-designated therapies. In fact the RMAT may be considered as analogous to the breakthrough designation for regenerative medicine drugs.