Reaching the finish line

For life sciences commercial teams, reaching the finish line of a drug launch is the culmination of years of preparation. Long before the drug's label is approved, teams are hard at work building educational and awareness campaigns that will support a strong launch. Essential pre-approval activities such as disease state education to raise awareness of unmet needs, “Coming Soon” brand introductions, and institutional promotion of the company’s research efforts all help lay the groundwork for the market debut.

With these early-stage efforts in motion, cross-functional marketing teams — both internal and external—collaborate intensively on branding and omnichannel strategies. Months before approval, they begin developing branded materials in anticipation of regulatory feedback, aiming to streamline the final push to market. By the time the label is approved, detailed aids, websites, storyboards, and other assets are already in process, ready for the final step in the journey: navigating the narrow and often slow-moving bottleneck of medical-legal-regulatory (MLR) review. Here, each asset undergoes rigorous scrutiny to ensure a compliant, on-time launch, paving the way for a successful entry into the market.

MLR in a nutshell

MLR is a crucial but painful process for most teams, commercial and regulatory alike. Teams must first verify the medical accuracy of claims made in promotional and educational documents by referencing them against hundreds of pages of scientifically-approved literature. Like finding a needle in a haystack, this process requires an exorbitant amount of manual effort and attention-to-detail, which oftentimes results in avoidable errors.

Teams then undergo a time-intensive regulatory review process to identify problematic language and ensure that statements align with brand guidelines as well as FDA 21 CFR regulatory standards. Validating a statement’s consistency with FDA labeling (CFL), determining whether or not a piece meets fair balance, and analyzing the nuances of claim construction usually result in hot debates between regulatory and commercial teams. The end result: multiple rounds of review and delayed timelines.

This process is repeated for every single form of content no matter the size, ranging from 100-slide detail aids to direct message responses for influencers.

An AI-enabled MLR platform for your team

We’re excited to introduce Solstice, the industry’s most sophisticated MLR tool. Solstice provides teams with an extra set of hands to rapidly accelerate the review process. The system leverages secure generative AI models to streamline much of the manual work involved in regulatory review, giving time back to marketing teams and ultimately helping teams meet commercial deadlines.

The platform accurately fact-checks claims against a knowledge base and flags statements that are non-compliant with company and industry standards. It understands specific requirements within brands while also distinguishing different requirements across brands, done by drawing patterns between prior-approved content as well as new suggestions made by reviewers.

By acting as an evolving knowledge base for a brand’s content and rules, Solstice allows teams to easily access precedents and evaluate drafts against previously approved language. The platform then allocates tasks between different review departments to most efficiently allow team members to collaborate on ideas, approve suggestions, and raise questions.

Solstice empowers every commercial and regulatory team member with the ability to evaluate new content in a compliant fashion within seconds.

Partner with us

By providing commercial and regulatory teams with a smart assistant, our vision is to elevate the important work that life sciences companies do in communicating their product’s value to physicians and patients. Time is money and errors are expensive. We know the amount of effort it requires to commercialize a drug. Let us lift some of the weight off of your shoulders so that you can focus on your bread and butter.

Visit us at www.solsticehealth.co for more information and sign up for a demo to see for yourself.

- Yiwen & Aris