Regulatory Affairs Expert Witnesses in Rhode Island

This expert is currently working through her consulting company, within the Pharmaceutical Industry as a consultant, providing guidance and service for all aspects of Regulatory Affairs for the entire product lifecycle of drugs and biologics from discovery to approval/launch and post-marketing. In addition, providing expertise in business development pertaining to regulatory intelligence and regulatory due diligence. Her experience includes serving as a member of the Management Team (SVP RA) for three small companies developing novel drugs and biologics, and building and leading a product compliance organization (RA, QA and CQA) for a small biotech company, including approval of their first monoclonal antibody product, while serving in a leadership role on the Management Team. Prior to that, have led regulatory activities for several NDAs (leading to marketed products), INDs and post-marketing regulatory activities in 3 large pharmaceutical companies. She has 5 years experience in small molecule API process development and a PhD in medicinal chemistry and is a frequent contributor to various Industry programs. Specialties: All aspects of Regulatory Affairs for entire product lifecycles for small molecules and biologics, including: -IND/NDA/BLA submission management, prosecution and strategy -FDA meetings -Regulatory Liaison activities -Ad/Promo review and advising -CMC

This licensed paramedic has over 37 years of EMS experience with 22 years in an administrative capacity. In addition, he has a plethora of certifications including EMS instructor, OSHA compliance instructor, and Emergency Vehicle Operator Instructor (EVOC). Finally, he has held several extremely prestigious EMS related positions including the Director of Emergency Management for Portland, CT before opening his own EMS training firm.

This expert has 40 years of experience as a wage and hour specialist. She worked for the US Department of Labor Wage and Hour Division for more than three decades, gaining extensive experience achieving compliance with the Fair Labor Standards Act, including white collar exemptions, regular rate in overtime computations, reconstructing hours of work, and child labor. She also has extensive experience in federal prevailing wage statutes, such as Davis Bacon, Service Contract Act and H-1B nonimmigrant employment standards. Currently, she is the Owner and Principal of her own wage and hour consulting firm, where she helps attorneys and their clients navigate the complex wage and hour laws in order to achieve compliance. She assists with conducting internal compliance audits, offers advice and support during federal and state wage investigations, and provides litigation support, including back wage estimates and expert testimony. She lectures for legal, human resource, and government agencies and holds membership in the Society for Human Resource Management, as well as the Northeast Human Resources Association.

This expert is experienced with fatality, catastrophic injury and personal injury cases. He holds multiple certifications in occupational safety & health and OSHA compliance. Expertise includes forklifts, boom lifts, scissor lifts, fall protection, machine guarding, work zones, scaffolds, excavations. He specializes in applying OSHA General Industry regulations, OSHA Construction regulations, and safety-related national consensus standards to working conditions. He frequently performs health & safety and OSHA-related inspections, audits, and assessments. He specializes in conducting hazard analysis and recommends corrective actions to reduce or eliminate these hazards. He trains workers, management and senior management, and helps clients assess and improve their safety management systems. He is a frequent speaker at conferences and webinars.

This expert holds a Ph.D. in Biochemistry and Pathology, a Masters degree ion Environmental Health and Radiation Health Physics and a Bachelors degree in Biology. He worked for several years in academic research related to pulmonary injury and disease and pulmonary carcinogenesis. He also worked a the director of an environmental testing laboratory. In addition, this expert worked as an industrial Hygienist and as the Director of Safety at Massachusetts General Hospital in Boston. For the past 15 years he has been an independent consultant in Environmental Health, Safety and Toxicology. He advises attorneys and testifies in legal matters. This expert has written several publications and books on both scientific pulmonary research and on Healthcare Safety and Regulatory Compliance. he continues to write and lecture on topics related to healthcare safety, general safety and OSHA compliance.

This expert has over 35 years of experience in science education and safety compliance. He has been recognized in Who's Who in Education, Who's Who in Science and Engineering, and Who's Who in Science Education in the World. He served as a K-12 science director and chemistry/physics teacher for several decades and has written over 10 books and over 300 safety columns on science laboratory safety. Among other positions, he currently serves as a Safety Consultant and Director of Environmental Health and Safety for a public school system.

This expert was employed by USDOL/OSHA for 20 years. Following that federal service, he became a self-employed safety consultant in 1992. He is in the 25th year of that practice. He is the author of a textbook on OSHA and safety regulations. More than 350 of his articles, columns, and Q&As have been published in newsletters, magazines, etc. This expert specializes in hazard recognition and abatement, site inspection, accident/incident investigation, and citation resolution. He has conducted a wealth of OSHA-type "hands-on" comprehensive inspections, with emphasis on manufacturing and other "factory" facilities (one of his focuses is on machine safeguarding), construction (especially roofing), and retail stores. He also works on "fall down" cases. He frequently works with attorneys, and has testified (combining deposition and court) more than 50 times. His consulting work is primarily in the northeast, but he has conducted his business in at least 20 other states, plus Switzerland and Belgium. This expert is often called upon to explain OSHA policies and procedures, and how to prepare for and respond to OSHA inspections, complaints, and citations. He is eager to discuss mitigation, control, and elimination of hazards, and other means (such as training) to enhance employee protection, even where OSHA compliance may have been achieved. His approach is often creative, as he is highly experienced in the Odyssey of the Mind program.

This certified Regulatory Affairs Professional has more than 20 years of experience ensuring compliance with the FDA. Throughout his career, he has managed 510(k) submissions, reviews, appeals, and clinical trials for a multitude of devices with applications ranging from dentistry to cardiology and neurology. Prior to launching his current consultancy, he served as a Director of Regulatory Affairs at medical device firms that manufacture class II and class III products. Have experience with: Catheters/Stents: IV administration sets, peripheral perfusion/infusion catheters, coronary perfusion/infusion catheters, thoracic catheters, chest drains and blood bags, embolectomy catheters, thrombus aspiration catheters, PTA, PTCA, CVC, ECMO, retrograde and antegrade hemodialysis catheters, urethral and ureteral catheters/stents, insulin administration, Closed System drug Transfer Devices (CSTD), non-roller cardiopulmonary bypass pumps and catheters, coronary and peripheral BMS, peripheral covered stents, aortic covered stents, DES, ureteral stents, urological stents, esophageal stents, intracranial aneurysm stents, pericardium covered stents, vascular grafts and vascular grafts with helix or nitinol reinforcement, and vascular patches. Biomaterials: bone void fillers, resorbable implants, hydroxyl appetite, hyaluronic acid, dental impression materials, PEEK, calcium carbonate, Beta TCP, imaging contrast agents, hydrogel dressings, lubricious coatings, artificial saliva, contact lenses and contact lens solutions, antimicrobial coatings, antithrombotic coatings, IIb/IIIa inhibitors, mTOR inhibitors, and omega3 coatings, injectors and pens, antimicrobial wound cleanser and bandages. Orthopedic/Dental: ACL/PCL screws, suture anchors, tacks, staples, spinal cages, trauma plates and screws, CMF, approximation pins and rods, dentures, veneers, dental implants/abutments, impression material, autoclave equipment, dental units, limb lengthening systems, and intra-oral x-ray equipment. Accessories: tunnelers, suture wings, convenience kits, stylets, peel away dilators, cannulas, scalpels, suture, guidewires, sheathes, extension sets, repair kits, luer valves, needle/syringes, blood vacuum tubes, needle safe devices, O2 regulators, radiation therapy patient positioning systems, radiation range compensators, sterilization biological and chemical indicators, and fiber wire docking stations. Hardware/Software: neonatal clinical trial software, firmware, RIS software, image repository software, ECG analyses software, TENS, MIRS, MMA, MDDS, EMC therapy, PACS, stereotactic tracking system, stereotactic software, patient monitors, ventilators, lift beds, TMS (transcranial magnetic stimulator), active tinnitus implants, Holter monitors, phototherapy devices, data fusion software, hyperbaric chambers, autoclave sterilizers, powered muscle stimulators, cryosurgical units, MDM workflow software, Doppler and GPS ultrasound scanners, GPS needle sensors, vascular access needles, RF, nerve block needles, fiber optical lasers, neuron stimulators, and therapeutic massagers, MIMS, viewing monitors, body contouring devices. Reusables: nasopharyngoscope, colonoscope, colposcope, neurological endoscope, sinuscope, arthroscope, and laparoscopes, instruments, tunneler rods, irrigation systems, therapeutic mattresses, OB/GYN scopes, patient cables and electrodes, scooters, vein graft tunneling systems, confocal optical imaging devices, and cannulae, 3DHD endoscopes, IR fluorescence and Indocyanine green endoscopes, measuring microscopes. General Surgery: surgical film, pressure mattresses, cryo-biopsy needle, surgical mesh, plugs, anal fissure drug suppository and delivery plunger, anorectic Nifedipine CTD, red light therapy dermatology lasers, surgical lasers, and Continuous Low Irradiance Photodynamic Therapy (CLIPT) for phototherapy drug activation, collection and transport media, disinfecting swabs and wipes, gastrostomy tubes.

This mortgage expert has 30+ years of lending experience, including management positions in residential and consumer lending, secondary marketing, loan servicing, compliance, and operations. He is an accomplished third-party underwriter and quality control reviewer of mortgage loans and operations for several classifications of mortgage lenders. He has been a national-level instructor for over 20 years and has taught hundreds of lenders, as well as taught examiners and regulators on the state and federal level for banks, credit unions, and mortgage bankers/brokers. He worked with the NMLS in designing the SAFE Act federal MLO exam and in reviewing and auditing SAFE Act licensing education programs. The expert is a past Director of the Community Lending Institute Education Department for the American Bankers Association and is also the past Board Director, Strategic Planning Committee Chair, and Education Committee Co-Chair for the Connecticut Mortgage Bankers Association. In addition, he is the author of an industry standard residential mortgage textbook that is used in several hundred U.S. colleges and universities. The expert current runs two small consulting practices that specialize in mortgage and consumer lending/compliance.