Our Director of Regulatory Affairs, Jeremy Richter, defines Tag’s Regulatory Center of Excellence and explains, drawing first hand from client experience, why pharmaceutical marketers need this resource now to improve speed marketing and reduce excess marketing spend.
What is a Regulatory Center of Excellence:
It is a centralized team of medical, legal and regulatory (MLR) subject matter experts assembled to substantiate and contextualize promotional review materials within the Life Science material approval process. It is our responsibility to balance the needs of our client’s commercial business, MLR review team, and the FDA. Our optimized solution provides Tag clients the opportunity to utilize specialized roles and responsibilities within our MLR “wheelhouse” including Medical Editing, Quality Control, and Traffic Management. Tag’s Regulatory Center of Excellence centralizes procedures, best practices, and knowledge into one team that mitigates risk while providing significant cost savings.
Why is it necessary now?
The pharma marketing industry is one of high volume and tight timelines under heavily scrutinized regulations. The necessity to not only get a job through medical legal regulatory review but to understand MLR nuances is most essential. Couple this “standard” way of working with today’s COVID-19 situation, and you have a real perfect storm. By centralizing all best practices, procedures, and knowledge into one place, the likelihood of successfully managing and scaling MLR services becomes much higher. Brands have new indications to launch, labels to update and marketers are currently in a mad rush to transition print materials to digital so that field reps can deliver to their HCPs. All these materials must receive MLR approval prior to dissemination. Our centralized team of experts allow our clients and production partners to remain focused on their “day jobs” as we confidently shepherd their materials through the process.
What is the biggest mistake that pharma marketers make when trying to navigate the medical legal regulatory process?
Pharma companies, their brands, and strategic agency partners need to be focusing on their next “big ideas.” Oftentimes the regulatory submission responsibility is added onto an existing role, and frequently takes the backseat to creative output. This way of working is counterintuitive to the compliance risks of Life Sciences marketing. We partner with our clients to move and focus the regulatory/compliance attention further upstream to help mitigate any issues prior to it being seen by a review team. This effort drives efficiencies and quality otherwise missing from agency capabilities. Efficient, quality submissions lead to less review cycles, less review cycles leads to higher cost savings.
Read here to learn how Tag’s Regulatory Center of Excellence helped one leading pharma brand achieve a 94% MLR submission rate.
Tag is the global creative production and sourcing partner to brands and agencies. We help pharma marketers increase speed-to-market and drive launch and regulatory excellence to effectively communicate with HCP and patients.