Solstice’s Regulatory Assistant allows life sciences marketing teams to verify content against internal and external brand requirements. Navigating a dynamic regulatory landscape and managing specific brand requirements present significant challenges. Promotional regulatory requirements differ based both on the channel and the audience type. Brands have different interpretations of requirements. The subjective nature of regulatory compliance makes the process lengthy and often prone to errors. Regulatory Assistant evaluates content against these requirements by not only simulating human reasoning but also conducting these task verifications across all separate “rules” using an agentic approach. We conduct regulatory check at a fraction of the time, evaluating content in a subjective way similar to how teams currently do it.

1. FDA 21 CFR Requirements

The Food and Drug Administration’s (FDA) 21 CFR requirements represent the set of fundamental rules that guide prescription drug marketing. We incorporate all of these requirements into the foundational system, allowing teams to have a baseline set of requirements that all content is evaluated against even before they start using the platform. These requirements are each evaluated using AI agents, who have very specified roles to interpret and review content against a guideline delegated to them. Think of agents as autonomous employees trained to implement specific tasks. Teams can interact with them and provide feedback on their suggestions just as they would with other members of their team. Our AI agent responsible for evaluating fair balance, for example, not only draws on rules outlined in FDA 21 CFR Part 202.1.7 but also continuously monitors regulatory changes to seamlessly incorporate new changes in these requirements.

Below is a list of our primary agents:

1. Ingredient Information: Agent 1 ensures that advertisements present ingredient information as required by section 502(n) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

2. Established and Proprietary Names: Agent 2 evaluates the use of proprietary names and corresponding established names in advertisements.

3. True Statement Requirement: Agent 3 verifies the true statement of information relating to side effects, contraindications, and effectiveness.

4. False or Misleading Information: Agent 4 identifies false or misleading claims in promotional material.

5. Fair Balance: Agent 5 measures the prominence of side effects and risk-related information compared to information related to the effectiveness of the drug.

6. Prohibition of Unsubstantiated Claims: Agent 6 identifies and flags claims that are not supported by substantial evidence or substantial clinical experience.

2. Internal Brand Requirements

Along external regulatory requirements, we understand that different teams have different interpretations of guidelines and may even have rules for themselves. We accommodate these nuances by providing teams with the capability to add rules specific to their brand. We assign new agents to each of these new rules and deploy them to evaluate content from multiple angles. With advancements in natural language processing (NLP) and large language models (LLMs), our agents are able to interpret rules with contextual reasoning capabilities similar to humans, empowering marketing teams to review content exponentially faster.

Looking ahead

Regulatory Assistant provides marketing teams with a library to store all regulatory requirements for any given brand. It enables them to focus on implementing unique campaigns without needing to worry about misalignments with brand strategy and meeting complex compliance needs. The platform expedites content evaluation without changing existing workflows. We are committed to addressing your needs in a compliant, secure fashion and adapting to constantly evolving regulations. This is only the start, and we’d love to partner with you. Reach out at www.solsticehealth.co for any questions.