Enjoy peace of mind as an LSM Consulting life science client knowing that your organization is fully compliant with all regulatory requirements. Our process increases efficiency and helps employees clearly define the impact of their role within the organization, as well as the skills and knowledge required for peak performance. 

As a result of working with us, our clients have addressed compliance gaps, enhanced overall effectiveness, improved stakeholder engagement and created ongoing inspection readiness. That’s a win-win! 

YOUR QUALITY, SAFETY AND COMPLIANCE TRAINING PARTNER

 DOCUMENTATION

LSM Consulting specializes in large-scale SOP gap analysis and remediation to maintain the highest levels of regulatory compliance, including: 

  • Comprehensive analysis against regulatory guidelines
     

  • Subsequent development of process maps and procedural documentation
     

Our proven approach to developing controlled documents ensures clear, concise and accurate explanation of each process and the roles required to execute it as well as alignment with relevant regulations, documented job descriptions and training roles. 

TRAINING

Our holistic approach to training development and administration is created using comprehensive concepts and proven instructional design and training development methodologies. Our team has decades of experience in this arena, which enables LSM Consulting to build high-impact training programs across all relevant functions and topic areas for our clients.

 

We focus on assigning curricula appropriate to all roles within the organization, ensuring that all employees are well trained and compliant with ever-changing regulations. Our cutting-edge training solutions include rapid e-learning development and high quality training video production.

SAFETY SERVICES

LSM offers a variety of services related to key pharmacovigilance activities, including supporting the development and implementation of safety governance, as well as helping our clients provide oversight of vendors to ensure they adhere to quality medical review and case processing practices.

PROJECT MANAGEMENT

Each of our projects is assigned a dedicated project manager with extensive experience managing projects in this domain. Our project managers work closely with clients to strategically outline clear timelines, processes, budgets and reporting expectations, with special attention to the critical success factors of the project. Potential risks are quickly identified and remedied.

OUR "4D" PROCESS

1

DISCOVER

 

We cannot correct an issue if we don’t know it exists. LSM provides gap analysis services to uncover hidden risk factors and create a strategic plan to move into full compliance and optimal performance. As a result of working with LSM Consulting, clients have addressed gaps, enhanced overall efficiency, improved stakeholder engagement and ensured company-wide inspection-readiness.

2

DEFINE

 

LSM leverages industry best practices and our expertise to provide a clear, informed vision of where their organization needs to be and how to get there.  We craft the right solutions for your organization, working collaboratively with you to create buy-in at every level.

3

DEVELOP

 

Our team of experts works with business leaders in top pharma organizations to develop critical strategies, high-level training plans and related materials, including training decks, eLearning modules, and fully-produced training videos. We also define process flows and procedural documentation that supports our clients’ ability to maintain the highest levels of regulatory compliance. 

4

DELIVER

Our team has decades of experience delivering training and documentation within several electronic learning management and document management systems, such as ComplianceWire and Veeva Vault. We can facilitate and administer your training for you, or train your employees to facilitate and administer it. Either way, we work with you to get your organization up to full compliance and optimal performance, addressing concerns you may have around change management and sustainability. Achievement of these critical milestones will result in your employees feeling connected, energized, engaged and equipped with the knowledge and skills they need to be successful.

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