ForensisGroup Drug Label Expert Witnesses are extremely experienced with years in pharmacology, with expertise is in drug label safety, regulatory, clinical, and technical sciences associated with drug label approval, QA/QC of clinical research services, and health policy. They also have backgrounds in the pharmaceutical and pharmaceutical packaging industries, along with dealing with the Food and Drug Administration (FDA) and its labeling regulations.
They work in drug label development and warnings, as well as conducting label comprehension studies for consumers. These drug label professionals provide expert witness services as drug label and safety experts for pharmaceutical, medical, and legal liability cases. Some of these actions include issues of failure to warn of known safety issues, inappropriate off-label use of prescription medicines, and injury caused by label instructions. Some of the common deficiencies that these experts address deal with the dosage form, the placement of dosage form alongside the proper name. medication strength, the route of administration, and information about the manufacturer.
They consult on Food and Drug Administration Compliance, preparing submissions to the FDA, quality audits and implementation changes, establishing quality assurance procedures, along with corrective action and preventative action (CAPA) compliance, such as root cause analysis and educational programs.
We’ve been helping attorneys, law firms, insurance companies, as well as other public and private agencies discover credentialed and knowledgeable expert witnesses since 1991, locating experts in over 10,000 cases. Submit a request or call us today for additional information on retaining an authoritative drug label expert witness for your case.