MEDICAL LEGAL REGULATORY (MLR) SUPPORT
Importance of a Well-Defined Medical Legal Regulatory Review Process
It is critical for companies to establish a well-defined medical, legal and regulatory review process. One of the predominant challenges organizations face is that MLR committee members often manage multiple competing responsibilities and priorities. Additionally, the volume of materials requiring review can fluctuate significantly, especially during a new product or indication launch. Having supplemental ongoing or temporary support can help organizations maintain compliance and meet deadlines more effectively.
EVERSANA ORCHESTRATE™ MLR
EVERSANA ORCHESTRATE™ MLR is a comprehensive, AI-powered and industry-integrated platform that is transforming the Medical, Legal and Regulatory (MLR) review process with guaranteed savings.
EVERSANA’s MLR Support Services
EVERSANA offers tailored support services for clients seeking assistance with the review and approval of promotional and non-promotional materials. Our MLR support covers both the U.S. and Europe and includes Medical Reviewers, Regulatory Reviewers, MLR Coordinators, and Medical/Scientific Fact-Checkers.
Approach
Our approach is value- and quality-driven, rooted in our cultural beliefs of Client Delight and being Patient Minded. We recognize the critical role the MLR committee plays in reviewing and approving promotional and non-promotional materials. We also understand that our clients’ MLR committee members manage multiple responsibilities beyond MLR support.
Services
- SOPs, Process and Systems Configuration Support
- MLR Training Support
- Medical Reviewer Support (U.S. and Europe)
- Medical & Scientific Fact-Checking Services
- Regulatory Reviewer Support
- MLR Coordinator Services
- AI MLR Solution
Expertise
EVERSANA’s Medical Content, Medical Review, and Regulatory Affairs leadership team brings extensive experience, including direct biopharmaceutical industry expertise and highly trained healthcare professionals with advanced life sciences degrees. Our years of experience enable us to support products throughout their entire life cycle and scale our solutions to meet evolving client needs.
Customizable and Scalable
We understand that every client’s needs—therapeutic areas, products, resource models, and budgets—are unique. EVERSANA partners with clients to develop flexible, scalable resource models that deliver the required service levels and meet key performance indicators.
Technology and Innovation
EVERSANA has deep experience with systems, databases, and technologies used for MLR review (e.g., Veeva Vault PromoMats and MedComms). We actively monitor industry best practices and trends, continuously evaluating solutions to improve operations and efficiency.