Defining Tag's Regulatory Center of Excellence

The MLR process is one of the most time-consuming aspects of getting drug tactics to market in Pharmaceutical advertising, requiring a deep knowledge of regulatory requirements for provider and patient content. A Regulatory Centre of Excellence can be the missing piece of the marketing puzzle, creating a more efficient and effective production solution.

What is a Regulatory Centre of Excellence?

A Regulatory Center of Excellence (CoE) is a centralised team of medical, legal, and regulatory (MLR) subject matter experts who can substantiate and contextualise promotional materials within the pharmaceutical approval process. Within the CoE, marketers have access to specialised roles and skill sets, including Medical Editing, Quality Control, and Traffic Management. A Regulatory Centre of Excellence centralises procedures, best practices, and knowledge into a cohesive team that works together to ensure tactics are routed as accurately and efficiently as possible to time to market while providing significant cost savings.

What can the CoE do to support marketers?

The challenges of the MLR process include the amount of time required for review and approval, as well as ensuring that nuances of language and feedback are understood. Centralising all best practices, procedures, and knowledge into one team can help drastically reduce speed to market by creating clearer, more accurate submissions and reducing iterations of content. The CoE can also monitor approval queues for feedback, ensure that any feedback is clarified for production teams, and route materials to the next step in the process. A centralised team of experts within a CoE allows pharma clients and production partners to remain focused on their day-to-day tasks as materials are expertly and seamlessly managed through the process.

How does this help marketers?

Pharmaceutical companies, their brands, and strategic agency partners need to focus on the next big idea. Often 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. Within the CoE structure, Tag works with pharmaceutical brands to move regulatory and compliance matters further upstream to help mitigate any issues prior to them reaching a review team. Accurate, quality submissions lead to fewer review cycles, incur less cost, and decrease time to an approved asset. Decoupling this function from agencies and allowing it to be supported by a production agency like Tag will also provide brands with significant savings – allowing you to produce more content with existing budgets.

Could your MLR process use an efficiency boost?

The establishment of a Regulatory Centre of Excellence (CoE) transforms the efficiency and effectiveness of navigating the Medical, Legal, and Regulatory (MLR) process in pharmaceutical marketing. By centralising expertise and best practices, a CoE streamlines the approval process, ensuring that promotional materials are both accurate and timely. This approach reduces the number of review cycles, mitigates compliance risks, and allows pharmaceutical companies to focus on innovation and strategic initiatives. The support provided by a CoE not only accelerates the time to market but also delivers significant cost savings, enhancing overall productivity and allowing for more content creation within existing budgets.

Tag works with brands to create and deliver impactful content at speed and scale. From creative production and activation to strategic sourcing and delivery, analytics, and subject matter expertise, we transcend digital and physical touchpoints to allow brand content and concepts to travel globally and connect locally, through flexible, tech-enabled solutions 

Contact us to discover how Tag can help accelerate your speed-to-market by optimizing your MLR Review process.