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We applaud and support the efforts of teams developing treatments for COVID-19. As a proven leader in regulatory affairs, we understand the challenges that come with crucial studies. We stand ready to help those working for answers to navigate complex regulatory issues.
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Cato Research, Your Reliable Partner

Cato Research (CATO) is an international regulatory and clinical contract research organization (CRO) that has been delivering successful outcomes for its clients since 1988. Through highly qualified and experienced personnel located in offices across North America, Europe, Israel, and South Africa, supported by strategic alliances with selected regional CROs, CATO offers tried-and-trusted international coverage.

CATO has the advantage of integrated regulatory, clinical, and scientific expertise. Our highly talented and experienced international team offers services from preclinical through IND (or equivalent), clinical development, and marketing approval to Phase 4 postmarketing research. Our track record includes successes across many different health products, including drugs, biologics, vaccines, cell therapies (including stem cells), nutriceuticals, medical foods, devices, and diagnostics. In terms of diseases and indications, CATO has been involved in a wide variety of projects with a dominant focus in oncology, neurology/CNS, and rare and orphan drug indications. This experience includes leadership of, and involvement in some of the most challenging and innovative products.

Therapeutic Expertise

What our Sponsors say about us...

“Dear Cato team,

Thank you so much for all your hard work which has resulted in our NDA being submitted one day earlier than our already extremely tight timeline.


All our partners were very surprised when we set such an ambitious timeline in April when we changed from a paper CR to an eCTD, and many have said they did not think we would make it.  But with your team spirit and hard work the impossible has been made possible."

-Specialty Pharmaceutical Company

Cato Research - International Contract Research Organization | Research Triangle Park, Durham, North Carolina
2017-11-21T21:16:33-05:00

-Specialty Pharmaceutical Company

Thank you so much for all your hard work which has resulted in our NDA being submitted one day earlier than our already extremely tight timeline. All our partners were very surprised when we set such an ambitious timeline in April when we changed from a paper CR to an eCTD, and many have said they did not think we would make it.  But with your team spirit and hard work the impossible has been made possible."

“…And a special thank you

"…And a special thank you to you and everyone at CATO.  You have been a very very valuable partner in this journey and we could not have gotten to where we are without you.  I deeply appreciate everything that you and your team at CATO have done for us and I look forward to continuing to have a strong relationship with CATO in the future as well.


Thank you again for all of your help.  We couldn't have done it without you!"

- Pharmaceutical Company Headquartered in Los Angeles, CA

Cato Research - International Contract Research Organization | Research Triangle Park, Durham, North Carolina
2017-11-21T21:12:43-05:00

- Pharmaceutical Company Headquartered in Los Angeles, CA

"…And a special thank you to you and everyone at CATO.  You have been a very very valuable partner in this journey and we could not have gotten to where we are without you.  I deeply appreciate everything that you and your team at CATO have done for us and I look forward to continuing to have a strong relationship with CATO in the future as well. Thank you again for all of your help.  We couldn't have done it without you!"
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Cato Research - International Contract Research Organization | Research Triangle Park, Durham, North Carolina

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Cato Research Blog

  • New FDA Gudiances for February 2020 and Upcoming...
    by Cato Research on March 4, 2020 at 6:28 pm

    By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Strategy, CATO SMS    Special Interest Guidances/Information Date Posted Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus […]

  • What’s New Health Canada? January and February...
    by Cato Research on March 4, 2020 at 5:52 pm

      By Alejandra Gomez Perez, M.Sc., Regulatory Affairs Associate   What’s New in:   Therapeutic Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/what-new-drug-products-health-canada.html Biologics and Genetic Therapies Directorate: […]

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