Product Safety Services
LMI understands that companies with approved prescription drugs and medical devices are required to track and report any adverse events (AEs) associated with their products to regulatory agencies, such as the US Food and Drug Administration (FDA). Members of LMI's Imaging Center Division have significant experience assisting these companies in meeting their governmental obligations.
LMI has the ability to produce AE documentation in either paper or electronic format, and is able to create electronic files with searchable text. LMI is also able to create and distribute Client Score Card reports, which track internal and FDA-mandated time lines, enabling clients and counsel to best manage their reporting responsibilities.