A leading pharmaceutical company needed to implement a better system of checks and balances for Medical, Legal, Regulatory review (MLR). Pharma/Biotech companies routinely conduct MLR on their product’s promotional materials to ensure that their products claims are medically accurate, legally safe and in compliance with FDA regulations. The pharmaceutical company’s marketers were using various internal and external resources, some of whom were not MLR specialists, to produce content and submit for MLR approval.
The pharma brand did not have dedicated resources in place, across the business, to accurately navigate the MLR process. Without a specialized resource, materials across multiple products and departments within the pharmaceutical company, were not reaching satisfactory compliance standards, leading to multiple rounds of edits, delayed speed to market and increased spend. Many marketing teams passed MLR “re-dos” to agencies of record as rush jobs, asking the agency to then handle the regulatory submission, which was not their area of expertise and resulted, in many cases, in increased billable agency hours. Internal teams were spending too much time on the logistics of the approval process, managing multiple agencies and projects, and not enough time on strategic planning.
We implemented Tag’s Regulatory Center of Excellence, a dedicated team with medical and creative expertise including a studio manager (with a medical and creative background), production artist, quality control, medical editor and MLR specialist. All materials are managed through Tag’s Regulatory Center of Excellence with regulatory team members available to attend creative and commercial planning meetings to guide materials from start to finish. This gives the pharma marketing teams, across products, the ability to better balance the needs of the commercial business and the FDA by editing content internally with regulatory compliance specialists, streamlining workflow, controlling cost and improving speed and approval rates.