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...
No Hesitation in Recommending CATO as a CRO that can Add Value to Any Project!
Their expertise and their valuable input in regulatory affairs allowed us to meet the timelines in these three countries.
As for monitoring, CATO's team did a great job in following up closely with the sites to get answers to multiple requests but also in being responsive to our demands.
We want to stress that the partnership spirit and the high degree of professionalism they demonstrated during this project was highly appreciated.
This is the reason why we are looking forward to continuing our collaboration for future studies.
Consequently we have no hesitation in recommending CATO as a CRO that can add value to any project."
- European International CRO
“…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
2660 Woodley Rd. NW Washington, D.C. 20008
San Francisco, California, USA
Mallinckrodt plc (NYSE:MNK) today announced it has entered into a licensing agreement for development and commercialization of NeuroproteXeon’s investigational, pharmaceutical-grade xenon gas for inhalation therapy being evaluated to improve survival and functional outcomes for patients resuscitated after a cardiac arrest.
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 […]