Enjoy peace of mind knowing that your organization is fully compliant with all current regulatory requirements. LSM Consulting takes a holistic look at your business against relevant regulatory requirements, identifying areas where you can rigorously address compliance gaps, build efficiencies, and help employees clearly understand the impact of their role within the organization.
As a direct result of working with the LSM Consulting team, your organization will benefit from more engagement at all levels of the business and the confidence that comes with ongoing inspection readiness. Your organization thrives, and we get the satisfaction of knowing we did our best work. That’s a win for everyone.
We offer a variety of services related to key pharmacovigilance activities, including development and implementation of safety governance processes, as well as supporting oversight of vendors to ensure they adhere to all applicable good pharmacovigilance practices (GvP) guidelines.
We can help you develop a process for either periodic electronic trial master file (eTMF) spot checks or a more comprehensive audit to ensure your eTMF is organized and populated in alignment with your trial master file (TMF) plan, standard operating procedures (SOPs), study plans and relevant regulations.