Over the past decade, our reputation has been built on the successful delivery of pivotal trials to support regulatory submission and approval. Dr. McLane and our Quality Assurance team track all approvals and regulatory audits of sites participating in trials overseen by Catawba Research.
28
FDA Approvals
4
Health Canada Approvals
1
DCGI (India) Approval
Sponsors have received 33 regulatory approvals for 505(b)(2), ANDA, ANDS, and NDA submissions based on the pivotal trials we have conducted
42 sites have been audited at least once by the FDA (some as many as nine times) with zero FDA Form 483 reports (483s) issued
A recent FDA site inspection of three India sites resulted in zero 483s as well as marketing authorization by the FDA
Our SMO sites have been audited by the FDA a total of six times and zero 483s have been issued
