50 Successful Marketing Applications
Since 1988
50+ Successful
Marketing Applications
A History of Impact in Drug Development
Mind the Gap(s): Early Identification of Issues is Key for a Successful NDA or BLA
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New webinar series presents:
Expedited Development:
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Breakthrough Therapy or Fast Track Designations
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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...

“…Your firm consistently supported our company

"…Your firm consistently supported [OUR COMPANY] in its clinical research efforts that resulted in [OUR COMPANY] being the first and only Canadian company to ever obtain a FDA PMA approval for a therapeutic medical device.


We have no reservations in considering CATO as an important partner for our future clinical endeavors and recommending CATO to other companies."

- Canadian Medical Technology Co.

2017-11-22T15:46:09-04:00

- Canadian Medical Technology Co.

"…Your firm consistently supported [OUR COMPANY] in its clinical research efforts that resulted in [OUR COMPANY] being the first and only Canadian company to ever obtain a FDA PMA approval for a therapeutic medical device. We have no reservations in considering CATO as an important partner for our future clinical endeavors and recommending CATO to other companies."

“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

2017-11-22T15:53:33-04:00

- 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."

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Cato Research Blog

  • What’s New Health Canada? August and September...
    by Cato Research on October 18, 2019 at 1:19 pm

    What’s New Health Canada? By Christine Straccini, B.Sc., C.C.R.P., Regulatory Associate What’s New in: Therapeutic Products Directorate: Biologics and Genetic Therapies Directorate: Medical Devices: […]

  • New FDA Guidances for September 2019
    by Cato Research on October 8, 2019 at 1:20 pm

    Special Interest Guidances/Information Date Posted Patient-Focused Drug Development: Methods to Identify What Is Important to Patients – Draft Guidance 30 Sep 2019 Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act – Final Guidance 27 Sep […]

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