Find an Expert
Medical Device Regulatory Submissions
She has extensive experience writing and compiling 510(k)s and PMAs for product clearance or approval with a well-established track record of success. Some of the device types she has experience include Surgical Instrumentation, Cardiac Ablation Systems and Catheters; Surgical, Ophthalmic…
Injection Molding Thermoplastics, new product development, material call outs, process de-bug
He performs injection molded part design reviews to insure the part is "molder friendly" and highly producible. He can assist with gate location, transition from metal to plastic reviews and optimise cooling for fastest cycles. He can interact with mold…
Pharmaceutical Imaging, Biological, Physical and Analytical Research, Pharma Commercial Viability
He served as the CEO, President of two public companies, one private company and also as the Chairman of the Board of a Not-for-Profit. His experiences include: managing research, clinical studies, finance, managing personnel, legal issues, patent issues, restructuring companies,…
Orphan Drugs: FDA/EU/Canada; FDA Approval; Drug Development: CMC, QA, QC, Manufacturing
12 product approvals from FDA including 6 new chemical entities, a 510k device, and three major pharmaceutical efficacy indication supplemental approvals. All received 5-10 years of regulatory exclusivity (Hatch-Waxman, Orphan Drug). These products are generating over $100 million dollars in…
Nursing, Medical Literature, Healthcare
Expert started her career as a medical/surgical and hematology/oncology nurse working at Children's Hospital. She received her master's degree in (clinical nurse specialist and nurse practitioner) pediatrics from the University of Delaware. Expert went on to take a position at…
Forensic & Clinical Psychology – Malingering, Trauma, Harassment, Employment Issues and Claim of Psychological Injury
Licensed Psychologist and Clinical Nurse Specialist (psychiatric/mental health) uses her more than 30 years of experience to provide psychological assessments and expert witness consulting in employment, personal injury, civil rights, disability and psychological & medical malpractice cases. Issues addressed include…
Antitrust, Banking, Damages, Demography, Discrimination, Finance; IP Surveys, Statistics, Economics
Expert and his firm are responsible for all Quality Control on all litigation support activities for the Department of Justice. With an office of 15 professionals in the Washington DC metro area, they sample and evaluate the work of multiple…
Medicine, Especially Pathology (Laboratory Medicine), Women\’s Health, Cervical Cancer, Breast Cancer
Expert has practiced diagnostic surgical pathology for over 20 years, with special interest and experience in gynecologic and gastro-intestinal pathology. She has participated in several clinical trials with pharmaceutical clients in these areas, and has practical knowledge of what is…
Clinical Anesthesiology, Surgical Recovery Room, Critical Care, Pain Medicine, Abused Drug
Current Practicing Anesthesiologist responsible for caring for individuals that use abused drugs on a regular basis. These individuals have both medical and psychological problems resulting from both recent and long term abuse of drugs. Treats individuals who receive care at…
Assessing Hospital, Governing Body and Medical Staff Liability, Risk, Vulnerability & Responsibility
Expert, author of a guide for assessing hospital liability, has more than 30 years successful multilevel, multidisciplinary management leadership and consulting experience in Fortune healthcare corporations. She has held management positions in six hospitals and consulted with more than sixty,…