Regulatory Affairs Expert Witnesses in Connecticut

We’ll help you retain an industry-leading Regulatory Affairs expert

Regulatory Affairs expert witnesses practice in a variety of fields, including pharmaceuticals, medical devices, biotechnology, food safety, and environmental regulations. Some of the most common specialties among Regulatory Affairs expert witnesses include clinical trials regulation, drug approval processes, FDA compliance, product labeling regulations, and quality assurance. They can opine on the effects of regulatory violations, non-compliance penalties, product recalls, adverse event reporting, and regulatory strategy development.

Find an expert witness near you

Select your state

What party are you representing?

Average Regulatory Affairs Expert Witnesses Court Fees

Review Fee

Deposition Fee

Court Fee

Regulatory Affairs Experts in Connecticut

See more Regulatory Affairs Expert Witnesses
Review Fee $480/hr
Deposition Fee $480/hr
Court Fee $480/hr

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.

Chief Regulatory Officer, A Leading Medical Device Consulting Firm in FL

Bachelor of Science (BS), Werner-Siemens School

New Smyrna Beach,

Connecticut

View profile
Review Fee $400/hr
Deposition Fee $400/hr

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

Principal, A Pharmaceutical Regulatory Affairs Compliance Firm

Doctor of Philosophy (PhD), University of Rhode Island

Waterford,

Connecticut

View profile

FAQs for Regulatory Affairs Expert Witnesses

What is the role of a Regulatory Affairs expert witness?

A Regulatory Affairs expert witness provides insight and testimony on matters related to regulatory compliance, product approval processes, and industry standards in various sectors.

In what types of cases can a Regulatory Affairs expert witness be beneficial?

These experts are crucial in cases involving pharmaceuticals, medical devices, food safety, environmental regulations, and any sector where regulatory compliance is key.

How can a Regulatory Affairs expert witness assist in a pharmaceutical case?

They can provide insights into FDA approval processes, drug safety regulations, labeling requirements, and other aspects of pharmaceutical regulatory affairs.

Are there subspecialties within the field of Regulatory Affairs that an expert witness might focus on?

Yes, some experts may specialize in specific areas like pharmaceuticals, medical devices, biotechnology, or environmental regulations depending on their experience.

Why is it important to have a Regulatory Affairs expert witness with industry-specific knowledge?

Industry-specific knowledge ensures the expert is familiar with the unique regulatory landscape of that sector, providing accurate and relevant testimony.

How does Expert Institute select its Regulatory Affairs expert witnesses?

Expert Institute offers a personalized approach to help you find the highest quality experts. We source actively-practicing professionals who match all your requirements for specialty areas, work experience, litigation history, fee range, certifications, location, and more.

Connect with the Regulatory Affairs expert witness you need to win your case

Close Icon

Your information will not be shared. View our privacy policy.