Defining Tag's Regulatory Centre of Excellence

Tag's director of regulatory affairs, Jeremy Richter, defines its Regulatory Centre 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 Centre of Excellence

It is a centralised team of medical, legal and regulatory (MLR) subject matter experts assembled to substantiate and contextualise 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 optimised solution provides Tag clients the opportunity to utilise specialised roles and responsibilities within our MLR 'wheelhouse' including Medical Editing, Quality Control, and Traffic Management. Tag’s Regulatory Centre of Excellence centralises 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 scrutinised 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 centralising 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 centralised 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.

Click here to read how Tag’s Regulatory Centre of Excellence helped one leading pharmaceutical brand achieve a 94% MLR submission rate.

- Jeremy Richter, director of regulatory affairs, Tag