7 Regulatory Filings Expert Witnesses Found

Biomedical Engineering, Sports Medicine - Medical device, Biologics, Manufacturing, Risk Management, Design History File, FMEA, Stem Cells, Biomaterials, Product Liability, Intellectual Property, Implant, Collagen, Device testing, Design Controls, Product labeling, CDMO, Quality/Regulatory, Allograft, Forensic Science, Accident Recon

Qualified Nuclear Engineering Officer in the US Navy First author for 3 peer-reviewed original scientific research articles 10+ years in medical device/biologics design, development, and manufacture 15 years in design and operational engineering Inventor on two biomedical patents

Insurance, Business Operations - Life insurance, annuities, agent licensing, appointment, commissions, terminations, contracting, regulatory requirements, operations, customer service, call centers, home office administrative processes, technology, compliance, file review

...Expert consultant backgrounds and experience include: • management of life insurance company interactions with agents/brokers/producers • management of various life insurance and annuity home office administrative functions • detailed knowledge of systems supporting insurance company operations and policy servicing • state & federal regulatory compliance • oversight of complex data production for large-scale audits Areas of expertise include: • life insurance agent/broker/producer licensing, appointment, commissions, terminations, regulatory requirements • life insurance and annuity policy suitability and appropriateness • policy underwriting and issuance • new business processing • customer service and call center operations • customer correspondence • administrative processes • administrative systems • administrative data and reports • policy cancellation or termination • death claim processing • customer complaint resolution • recordkeeping/record retention • compliance with state and...

Fraud, Investigation - Data analytics, machine learning, fraud, financial crime, forensic accounting, securities fraud, complex investigations, asset investigations, investment due diligence, proxy contests, shareholder disputes, risk assessment for mergers and acquisitions, public records research, public corruption, AML

...Conduct extensive investigations for investment due diligence, asset investigations, litigation support, shareholder disputes, bankruptcy and regulatory matters. Specialize in securities fraud, organized crime and corruption. Assist both activist investors and public companies with in-depth research regarding proxy contests. On behalf of clients, have uncovered multiple material misrepresentations and omissions, undisclosed related party transactions, potential fraudulent transfers, potential bribes and bid rigging, instances of resume and investment misrepresentations, poor corporate governance, and reputational risks related to criminal, financial, regulatory and personal misconduct. Data analytics experience includes obtaining, joining and analyzing large-scale data sets encompassing millions of records to uncover investigative findings and patterns....

Pharmaceutical Research, Chemistry & Chemicals - API process development, API manufacturing, Solid state and physicochemical characterization, enabled formulation development, drug product development, drug product manufacturing, stereochemistry, process impurity identification, control, synthetic route selection, preformulation, polymorphism

...SERVICES OFFERED: • Expertise in Chemical Development o Evaluation and optimization of synthetic routes to drug candidates o Adaptation of discovery chemistry routes for scale-up o Chemical process development and optimization o Creation and execution of fit for purpose R&D, production and cGMP manufacturing strategies and plans o Design of syntheses of stable isotope and radiolabeled molecules for in vivo studies o Physicochemical characterization o Solid state chemistry – polymorphism, salt screening and selection o Sourcing of raw materials, excipients and standards • Vendor Selection, Engagement and Management o API, drug product, analytical, custom synthesis, QA and regulatory support o Creation of requests for proposal o Definition of scope of work, deliverables and timelines o Facilitation of performance and completion of work o Technology transfer - assembly of tech transfer packages, performance of tech transfer to and between vendors and organizations o Excellent vendor network...

Insurance, Products Liability - Asbestos, Pollution, Premises Liability, Occurrence Limits, Agent's Liability, Sexual Abuse, Stacking of Limits, Property, Businessowners, Professional Liability, Claims Handling, Compliance.

...At The Home was responsible for all regulatory compliance as well as the relationship with insurance regulators and legislators. Had overall responsibility for all product development, state filings, and market conduct examinations. Worked with line departments, especially Major Accounts, to tailor standard products to meet the needs of large account policyholders. Have provided expert opinions on a broad range of P&C topics and on a health case.

Pharmaceutical Regulation, Warnings & Labels - Pharmaceutical Industry, Drug Development, Product Labeling, Regulatory Labeling, Prescribing Information, Indications, Dosage, Contraindications, Warnings, Precautions, Adverse Experiences, Regulatory Compliance, Safety, FDA, Off-label Use

...Gain consensus and champion proactive consensus-building across Research, Statistics, Regulatory, Joint Ventures, Legal, and Marketing on labeling - laser-focused on the bottom line: “What do the doctor and patient need to know?” Provide leadership in support of label development for new applications, supplemental applications, revision filings based on new clinical data, new safety information, local labeling, new guideline compliance, and agency comments. Responsible for labeling for headquarter Company Core Data Sheet (CCDS), US (USPI), EU (SmPC), Rest of World, and Japan. Develop, lead label development, gain consensus, and shepherd labeling through management review as Chair of Worldwide Product Circular Review/Approval Committees. Tackle >25 products concurrently across the full product life cycle from Target Product Labeling through Phase II, Phase III, and Post Marketing, and in Adverse Experience Reports....

Safety, OSHA - 1910 General Industry, Accident Investigation, Fall Protection, Haz-Com, Hazard Recognition, Logistics Safety, OSHA Record Keeping, OSHA Standards, Powered Industrial Truck Operations, PPE, Risk Management, Root Cause Analysis, Safety Training, Warehouse Safety, Workplace Injuries

...He can speak to a wide range of health and safety topics and the applicable regulatory requirements. He has a Bachelor of Science in Occupational Health and Safety and is certified through the BCSP and holds a current Certified Safety Professional certificate (CSP). He has in the past been a certified First Aid class trainer, respirator fit tester, and done industrial hygiene sampling work. He is very familiar with the OSHA 29 CFR 1910 General Industry Regulations, and also has experience with the OSHA 29 CFR 1926 Construction regulations as well. He is proficient in accident investigation, root cause analysis, OSHA standards, OSHA recordkeeping, powered industrial truck operations, warehouse safety, logistics safety, fall prevention, hazard recognition, personal protective equipment (PPE), safety training, risk management, haz-com, 1910 general industry, and workplace injuries. Mr....