Regulatory Affairs Expert Witnesses in New Mexico

This expert is a pharmacist and a pharmacologist and a former professor at Yale University and Georgetown University. He is also a former FDA Medical Officer/Senior Medical Analyst, who is an expert in the areas of drug Safety, drug development, regulatory affairs and FDA policy. He as also served as an advisor on the 2016 Ted Cruz presidential campaign, and has also been invited to testify in front of the U.S. Senate as a healthcare policy expert, FDA expert and Pharmacology expert. He has authored or co-authored over 50 publications, papers, articles, reviews, clinical protocols and reports in many related areas including FDA law, drug pricing, healthcare policy, healthcare insurance, drug development and drug patent law.

This highly qualified expert has more than 40 years of international experience in the development and implementation of occupational health, safety, and environmental (HSE) management systems within the petroleum, petrochemical,manufacturing, and construction industries. He is an advisor to management on regulatory compliance with worldwide agencies such as BSEE, EC, OSHA, HSE, PSA, SSM, DEA, USCG, MSHA, MMS, NOPSA and other applicable industry standards and codes. He is experienced with ISO, ISM, Injury Incident Free (IIF) culture building, root cause analysis, and behavior based safety; including 24 years experience with stringent safety requirements of the North Sea regulatory agencies.

This FDA regulation expert earned her B.S. in Environmental Chemistry from Purchase College and her M.S. in Environmental Science from the University of Colorado Denver. She began her career with the FDA in 1987 as a Chemist in the Denver Districts Laboratory and then became a Compliance Officer in 1992, specializing primarily in medical device and biologics cases. She later managed a group of eight investigators as a Supervisory Consumer Safety Officer and then became a Compliance Officer, tasked with evaluating reports and lab analysis to determine compliance with regulation. The expert finished her FDA career as a Senior Case Review Expert, a role she held from 2008 until the end of 2015. In this position, she was responsible for reviewing and evaluating proposed judicial actions to determine if they were compliant with the requirements of the the Federal Food, Drug, and Cosmetics Act and other regulations. Currently, the expert runs her own consulting business.

This expert has successfully aided many national and international medical device companies with on-site help during FDA audits, FDA-483 responses, Warning Letter Responses, Consent Decree Corrections, ISO audits and readiness, developing and implementing compliant quality systems. She is a former FDA Regional Medical Device Expert and currently provides personalized, FDA regulatory and quality solutions and training to both small and large companies, and entrepreneurs. This expert has been invited to speak nationally, and has authored 6 publications in FDA regulatory and quality matters.

This highly qualified expert is a certified director of safety with 8 years of experience in the upstream oil & gas industry in managing Department of Transportation compliance and HSE system as well as a comprehensive working knowledge of SH&E issues and governmental regulations. He received his BS in organizational leadership at Mountain State University before going on to complete his MA in business and organizational leadership at Webster University in St. Louis. He is a certified director of safety, advanced accident reconstructionist and aircraft crash investigator. He has previously served as a Texas state trooper for the Texas Department of Public Safety and currently serves in public safety as the director for the national investigative services division at an organization in Georgia specializing in homeland security. He has also previously served as safety director, manager and DOT compliance administrator for various organizations, including, Expedited Logistics and Freight Services, Hyperion Safety Services and Baker Hughes. Currently, he serves as manager for DOT and compliance at a transportation company in Texas.

This expert earned his BS in health and exercise science and his MS in toxicology from Colorado State University and his MS in health services administration with a concentration in biopharmaceutical regulatory compliance and his PharmD from the University of Wyoming. He is active in his field as a member of the National Community Pharmacists Association and the American Pharmacist Association. He formerly served as a pharmacy intern and the flu clinic supervisor for the student health pharmacy at the University of Wyoming. Currently, this expert is a medical content writer for a medical consulting firm.

This expert has been working in the petroleum industry for over 40 years. He has worked for numerous petroleum and energy firms in a variety of capacities, from production and drilling accountant and oil and gas accountant to senior internal auditor, control analyst, audit manager, and senior staff auditor. Awarded the honor of Fellow of the American College of Forensic Examiners, he holds a number of certifications for auditing, fraud examination, and consulting, while he has held membership in the Council of Petroleum Accountants Societies for over 40 years. Currently, this expert runs his own petroleum consulting firm, where he provides services in the areas of auditing, negotiation, reviews, due diligence, fraud, litigation support, and joint interest and contract compliance. His clients have included Amoco, Chevron, Exxon, and Texaco, among many others, and his audits have returned exceptions of up to $60 million. This expert is an author and widely published.

This expert is a certified life care planner and nurse consultant with clinical background in nursing, orthopedics, rehabilitation and critical care medicine. She has extensive background in evaluation of complex and long term needs of clients who have suffered catastrophic injuries. She holds expertise in health care quality and risk management, health care administration, and regulatory compliance. She has been a certified life care planner since 2010.