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...
Our CATO team has been really delivering for us.
Our CATO team has been really delivering for us. We have had a lot of Information Requests throughout the NDA review and have provided a number of submissions to CATO, very late in the day often at inopportune times, despite intensive planning from the moment of receipt. We do not wish to make a habit out of this and continue to strive to ensure there is fair and adequate time for everyone to do their job under reasonable circumstances. Our team has consistently delivered, and gone above and beyond over and over.
- North America Biopharmaceutical
Congratulations Team! Another Approval!
I have shared the approval letter with the Executives.
- A Canadian Innovative Drug Company
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
New FDA Guidances for October 2019 and Upcoming...
by Cato Research on November 6, 2019 at 3:09 pm
By Sheila Plant, PhD, MHS, RAC (US), Director, Regulatory Strategy at Cato Research Special Interest Guidances/Information Date Posted Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 – Draft Guidance 01 November 2019 Chronic Hepatitis D Virus Infection: Developing Drugs for […]
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: […]