50+ Marketing Approvals
"We Do the Hard Stuff"
If you have faced challenges on the way to a product approval, have you asked what could be done differently if more knowledge and expertise were available in regulatory or clinical trial strategy?
Here are just a few examples of sponsor requests to Cato Research in the last couple of months:
- Sponsor came to CATO on clinical hold and was unhappy with the service provided by a large CRO. CATO identified and corrected CMC deficiencies, negotiated removal of the clinical hold, and initiated a phase 2 clinical trial within 6 months.
- Sponsor’s external scientific advisor failed to produce Quality documents. CATO medical writers revised and completed CMC and nonclinical IND sections within 2 weeks for this cell-based therapy, keeping the sponsor’s externally announced timelines intact.
- Sponsor received RTF letter on its first NDA. CATO revised, reanalyzed and resubmitted the NDA, which was filed and approved within one year.
Cato Research is a mid-sized Contract Research Organization (CRO) with over thirty years of acquired knowledge and experience. With more than fifty (50) marketing approvals obtained, 800 clinical trials completed and 400 annual regulatory submissions made per year, Cato Research has the expertise and experience in Regulatory Strategy, Clinical Trial Operations, and Chemistry, Manufacturing, and Controls (CMC) to support your projects.
We look forward to introducing you to Cato Research and the solutions-oriented expertise we provide.