Regulatory Knowledge and Support (RKS) provides guidance and support on regulatory governance including IRB and FDA.
We want to help you navigate through regulatory requirements more easily and help you ensure compliance.
Our services include:
- advice and support with IRB and FDA requirements
- in-house Clinical Research Monitoring Service for people with INDs and IDEs to ensure quality & compliance
- assist you with submitting IND and IDE application to the FDA
- provide consulting on ClinicalTrials.gov requirements