Expert 518266 - TX

Expertise Description

I have more than 35 years in Pharmacology and more than 25 years in senior management within the industry. My expertise is in drug safety, drug and device development, regulatory, clinical and technical sciences associated with drug and device approval, QA/QC of clinical research services, health outcomes research, and health policy. My company has provided regulatory program development and operational management for drugs and devices, as well as safety and efficacy programs in support of drug approval and postmarketing surveillance, label development and warnings, and label comprehension studies. I also have experience with clinical site management, including QA/QC facility audits of clinical sites and CROs and renovation of quality management systems. I have over 10 years of expert witness experience with consultation, deposition, and courtroom testimony.

Expert 518320 - NJ

Expertise Description

I have over than 25 years of experience in drug development, clinical manufacturing and drug delivery systems. I have been Principal of a firm that provides guidance in all aspects of drug product development. These subjects include: sterile product subject matter, peptide and protein formulation, drug delivery, aseptic processing, sustained release parenteral, excipients, inter partes patent review, technology transfer, injection devises, solubilization, and patent infringement and validity. I also have substantial GMP, FDA R&D and manufacturing experience. I have prior expert witness experience with consultation, deposition, and courtroom testimony.

Expert 376252 - CA(N) CA(S) FL IL LA NJ PA

Expertise Description

I have over 15 years experience in the field of Biomedical Engineering. My experience and comprehensive background includes medical device and development, implantable cardiac defibrillator, cardiac resynchronization therapy devices, cardiac pacemaker, artificial organ design, heart failure, cardiac device research and development, cardiac pacing paradigms, clinical engineering, preclinical and clinical medical device trials, FDA device controls and regulatory protocols, intellectual property IP issues related to cardiac devices, clinical engineering, medical device quality controls, laboratory and clinical research, collection of data, and evaluation and documentation of test results. My other areas of expertise include Artificial Organ Design (cardiology and neurology), Cardiac Echocardiography, Cardiovascular Therapy Devices / Systems, Neurological Therapy Devices / Systems, Physiological Monitoring, Cardiac Electrophysiology, Heart Failure studies, Patent Protection Issues. I have prior expert witness experience.

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