Breakthrough Therapy or Fast Track Designations
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.
What our Sponsors say about us...
“…Thanks to all of you!
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
“Dear Cato team,
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
Carlsbad, CA, USA
2660 Woodley Rd. NW Washington, D.C. 20008
Cato Research Blog
New FDA Guidances for June to August 2019
by Cato Research on September 9, 2019 at 7:07 pm
Special Interest Guidances/Information Date Posted Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions: Guidance for Industry and Food and Drug Administration Staff – Final 30 August […]
What’s New Health Canada? June and July 2019...
by Cato Research on August 26, 2019 at 5:39 pm
What’s New Health Canada? By Christine Straccini, B.Sc., C.C.R.P., Regulatory Associate What’s New in: Therapeutic Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/what-new-drug-products-health-canada.html Biologics and Genetic […]