MathurConsulting

Pharmaceutical industry consultation for clinical device and drug development (phases I-IV) and medical marketing support. Services have included clinical trial design and implementation, site selection and screening, development of clinical documents for major regulatory filings (e.g., 9 successful NDAs), preparation for and participation in >20 FDA meetings, >20 INDs, medical monitoring of >50 trials, investigator device training, medical education, publications planning and writing, sales and advisory board training, management of product registries, and assessment of data and clinical development strategy for new product or investment opportunities. National and international clientele. Served as acting CMO of start-up. Therapeutic areas have included acute CHF, urgent/emergent and chronic HTN, stable coronary artery disease, angina, acute renal failure (surgical and non-surgical), dialysis access, CRRT, chronic kidney disease complications (anemia, pruritis, hyperkalemia), chronic and acute pain, transplantation (renal, cardiac, and neuronal), Hepatitis B, Meningococcus, H. Pylori (vaccines/immunotherapy), Flavivirus vaccines, asthma, COPD, myocardial perfusion imaging, oncology, CNS.