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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.

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What our Sponsors say about us...

Very impressed with the quality and efficiency that Cato…

"I’m very impressed with the quality and efficiency that Cato put into the protocol. Kudos for your team. I am hoping that we will have more collaboration with you in the near future, not only for NDA, but for other technical writing projects."

- Vice President of Medical, Southeast Pharmaceutical Company

Cato Research - International Contract Research Organization | Research Triangle Park, Durham, North Carolina
2019-11-08T15:45:27-05:00

- Vice President of Medical, Southeast Pharmaceutical Company

"I’m very impressed with the quality and efficiency that Cato put into the protocol. Kudos for your team. I am hoping that we will have more collaboration with you in the near future, not only for NDA, but for other technical writing projects."

Type C Meeting with FDA

Dear CATO team,

On behalf of the our team, I would like to thank you for your support at the Type C meeting with FDA as well as your great input and challenge at the prep meeting. We could secure the outcome that we wanted to achieve!

- VP Global Regulatory Affairs

European Pharma Company

Cato Research - International Contract Research Organization | Research Triangle Park, Durham, North Carolina
2019-12-06T10:51:16-05:00

- VP Global Regulatory Affairs

European Pharma Company

Dear CATO team, On behalf of the our team, I would like to thank you for your support at the Type C meeting with FDA as well as your great input and challenge at the prep meeting. We could secure the outcome that we wanted to achieve!
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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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