Medical, Legal, and Regulatory Review Process
Emerging life science companies face a unique challenge when it comes to managing compliance risk for publicly available materials that have not undergone peer review. This includes medical affairs materials such as scientific slide decks and website content, as well as commercial promotional materials such as detailing aids and advertising.
Establishing Medical/Legal/Regulatory (MLR) processes, software workflows, and required policies and standard operating procedures (SOPs) can be a daunting task for first time launch companies.
Staff involved in MLR processes may have experience participating in them but have not had the opportunity to build them from scratch. Often the churn around establishing MLR distracts staff from other more pressing topics.
As a highly cross-functional process, there can be wide variances in experience and opinions on how MLR capabilities should be set up. Questions that often arise include:
- Should we implement Veeva MedComms for medical material workflows and/or Veeva PromoMats for promotional review workflows?
- When should we implement our first Veeva Vault for MLR?
- Are there interim, fit-for-purpose solutions or steps we may consider as a de-risking strategy?
- What resources do we need to operate the processes?
Limited staff focused on developing and executing medical and commercial strategies often do not have the time to work through the due diligence required to answer these questions, design the capability, implement it, and perhaps operate the processes once established.
Often the result is conflict within the organization especially as companies approach approval, everyone’s calendars are maxed out, and the volume of material submitted for review is overwhelming.
INSIGHT: Medical Affairs Impact and Performance
SVA Life Sciences has extensive experience building and operating MLR processes. As a Veeva Partner, we have knowledge and access to the right people and resources from Veeva across their solutions.
Our team of business analysts are experienced in guiding cross-functional teams towards an aligned view on how to build fit-for-purpose MLR capabilities, from surfacing of first needs from Medical Affairs to when an onslaught of commercial promotional material review needs arise in anticipation of launch.
INSIGHT: Corporate Launch 101: Why Organizational Readiness Should be Priority of First-Time Launchers
Our resources provide multiple services such as:
- Developing an MLR strategy and plan including pro and con options for what Veeva Vault software to purchase and when
- Developing requirements required by Veeva in preparation for the implementation of MedComms and/or PromoMats
- Serving as the "owner's representative" during Veeva implementation to relieve pressure on staff
- Chartering and facilitating the establishment of the Medical Material Review Committee (MRC) and Promotional Review Committee (PRC)
- Conducting an inventory and forecast of anticipated MRC and PRC volumes to prepare staff for heavy workloads
- Facilitating the MRC and PRC processes including expediting revisions and administration of the Veeva Vault systems in lieu of hiring administrative staff
If you are interested in learning more about SVA's services and how we can help your company manage critical processes without adding staff burden, contact us for a 30-minute information exchange to discuss your situation. We would be happy to share what we have learned and experienced with other organizations like yours.
By working with SVA Life Sciences, you can have peace of mind knowing that your MLR processes are in good hands, allowing you to focus on developing and launching your products.
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