Breakthrough Therapy or Fast Track Designations
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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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We have no reservations in considering CATO as an important partner for our future clinical endeavors and recommending CATO to other companies."
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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Guidances/Information Date Posted Patient-Focused Drug Development: Methods to Identify What Is Important to Patients – Draft Guidance 30 Sep 2019 Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act – Final Guidance 27 Sep […]