Experienced in and knowledgeable on clinical/regulatory SOP's, GCPs, GLPs and regulatory reviews for FDA and ICH guidelines. Auditing and monitoring of clinical trials of pharmaceuticals, medical devices and combination products. Prepared and advised on FDA filings, including INDs, NDAs, 510ks, IDEs, PMAs and In vitro Diagnostics. Monitoring and audited patient and product data prior to FDA submission. Writes protocols, scientific/medical and monitoring reports. Assists in organizational re-engineering. Conducts clinical trials on new clinical products. Has conducted clinical trials in Alzheimer's, schizophrenia, memory problems, heart-valves (mechanical and tissue), silicone gastric bands, liposuction wands, surgical sutures, stents, dental video equipment, anesthesia, in-line glucose sensor, sexual dysfunction, Parkinson's, arthritis, restenosis, glaucoma, anti-infective, diabetes, anti-platelet, gastro-intestinal and MRI contrast agent.
A brochure of services is available by email