Extensive knowledge in: New Drug Application (NDA) Files; Investigational New Drug (IND) Files; Reporting of Suspected Unexpected Serious Adverse Events (SUSARS); Incident Record Form (IRF); Medical History; Case report form (CRF); Scientific Articles; Regulatory guidance; GPM; SOP. In the last 3-4 years I’ve extensively worked with Clinical Trial Protocols, Patient questionnaires. Clinical study Reports, Ivestigator’s Brochure, New Drug Application (NDA) Files, IFUs, and Lab manuals.