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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...

“…Thanks to all of you!

"...Thanks to all of you!  You guys are terrific!  It's a real pleasure to work with you.  Thanks to all the efforts and professional work.  Looking forward for the next phase on this project!
Please find attached the APPROVAL letter for Product.  Please share in our excitement as you have been partners in this adventure!"

Global U.S. Biotechnology Company

Cato Research - International Contract Research Organization | Research Triangle Park, Durham, North Carolina
2017-11-21T21:08:17-05:00

Global U.S. Biotechnology Company

"...Thanks to all of you!  You guys are terrific!  It's a real pleasure to work with you.  Thanks to all the efforts and professional work.  Looking forward for the next phase on this project! Please find attached the APPROVAL letter for Product.  Please share in our excitement as you have been partners in this adventure!"

“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."
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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 July 2020 and Upcoming...
    by Cato Research on August 5, 2020 at 7:46 pm

      By Joshua Taylor, PhD, RAC, Director – Regulatory Affairs at CATO SMS    Special Interest Guidances/Information Date Posted Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans – Final Guidance 31 Jul 2020 […]

  • Are you ready for the new European clinical trial...
    by Cato Research on July 20, 2020 at 7:07 pm

    29 June 2020 – Cleo François MSc, Regulatory Affairs Manager The new European Clinical Trial Regulation (ECTR) will replace the 2001/20/EC Directive, the directive that currently describes how clinical trials should be conducted in Europe. The main objectives of the new ECTR are to make […]

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