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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...

“Thank you for your continued support and valuable contribution…

"We would like to share some good news with the Cato Team. Yesterday, we received FDA Breakthrough Therapy designation for our [ABC Drug].

On behalf of our company, we would like to thank you for your continued support and valuable contribution to the success of our regulatory submissions."

- Biotechnology Company Headquartered in Rockville, MD, USA

2017-11-22T15:53:33-05:00

- Biotechnology Company Headquartered in Rockville, MD, USA

"We would like to share some good news with the Cato Team. Yesterday, we received FDA Breakthrough Therapy designation for our [ABC Drug]. On behalf of our company, we would like to thank you for your continued support and valuable contribution to the success of our regulatory submissions."

Pleasure working with all of the folks at CATO

It has been a real pleasure working with all of the folks at CATO that have touched our IND over the years for all the various submissions such as Protocol Amendments, Information Amendments, Request for Meetings and SPAs, IND Safety Reports, and Annual Reports.

The quality review and attention to detail has been exceptional. The guidance you provided to format and structure was very helpful and allowed us to be more efficient in our work.

I appreciate all your hard work and commitment to our program! Hopefully we will cross paths again.

- Biotech in Cambridge, MA, USA
Head Clinical/Regulatory Operations

2018-01-29T20:37:12-05:00

- Biotech in Cambridge, MA, USA
Head Clinical/Regulatory Operations

It has been a real pleasure working with all of the folks at CATO that have touched our IND over the years for all the various submissions such as Protocol Amendments, Information Amendments, Request for Meetings and SPAs, IND Safety Reports, and Annual Reports. The quality review and attention to detail has been exceptional. The guidance you provided to format and structure was very helpful and allowed us to be more efficient in our work. I appreciate all your hard work and commitment to our program! Hopefully we will cross paths again.

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Cato Research Blog

  • New FDA Guidances for November and December 2019...
    by Cato Research on January 6, 2020 at 9:36 pm

    By Alice Li, MD, MSc, RAC(CAN), Regulatory Scientist, Cato Research Special Interest Guidances/Information Date Posted Guidance for Industry: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, […]

  • What’s New Health Canada? November 2019 Updates
    by Cato Research on December 20, 2019 at 2:41 pm

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

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