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.
Claudia Lewis is a seasoned executive with over 20 years experience leading operations, financial management and strategy for companies in the technology, pharmaceutical and non-profit sectors.
PARTNER AND CHIEF OPERATING OFFICER
PARTNER AND CHIEF EXECUTIVE OFFICER
Liimu McGill has more than 20 years of experience consulting to the pharmaceutical industry, and for the past 12 years has had the honor of building LSM Consulting to be one of the leading providers of training and documentation services for regulated environments within the pharmaceutical industry.
Our staff and consultants are selected based on their skill level and expertise, as well as their alignment with our company values and the values of the clients we serve. As a result, every team member brings his or her own unique expertise to each project, and we have a shared commitment to the overall success of each project that ensures we all work together to achieve the project objectives. No egos, just outcomes.
STAFF & CONSULTANTS
"LSM Consulting was instrumental in the design, planning and implementation of the Otsuka Global Pharmacovigilance Medical Safety departmental onboarding training initiative, creating a comprehensive, interactive and engaging program that included both instructor-led training and eLearning modules in a multi-day-long experience for attendees.
The team supported our counterparts with full customer service and accessibility. They met the target timelines, although aggressive in some instances, with ease. We were extremely satisfied with the overall journey and deliverable output from LSM Consulting which enabled us to evolve our organization’s ability to independently manage our inspection readiness training needs and requirements."
Associate Director, Clinical Management,