Welcome!

This interactive, up-to-date repository of resources is a comprehensive web portal where anyone can easily access information from government, academic, and scientific institutions, with the goal of providing clinical research workforce with the regulatory information to plan and conduct clinical trials and bring their bench discoveries to the patient's bedside.

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Interested in a degree in Regulatory Science?  Visit the USC Mann Department of Regulatory and Quality Sciences

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Created and maintained by the Southern California Clinical and Translational Institute (SC CTSI) Regulatory and Knowledge and Support (RKS) core, this work is supported by grants UL1TR001855 from the National Center for Advancing Translational Science (NCATS) of the U.S. National Institutes of Health. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Table of Contents

  1. What is my medical product?
  2. What stage am I in the product development process?
    1. Clinical Research
      1. Therapeutics
      2. Devices
    2. Patenting
      1. Therapeutics
      2. Devices
    3. Manufacturing
      1. Therapeutics
      2. Devices
    4. Commercialization
      1. Therapeutics
      2. Devices
    5. Post-market - Devices
  3. Regulatory Consultation Services
  4. Glossary of Terms Used in Regulatory Science
  5. Tell us what you think!

NIH Funding Acknowledgment: Important - All publications resulting from the utilization of SC CTSI resources are required to credit the SC CTSI grant by including the NIH funding acknowledgment and must comply with the NIH Public Access Policy.