The Client

Our client is a dynamic player in the Over the Counter (OTC) marketplace, having recently acquired an over-the-counter product from a consumer healthcare company. Recognizing the potential of the product, the client aims to optimize its claims and explore additional possibilities for marketing and packaging design. They sought our expertise to review their documents and filings, strategize on language for marketing communication, and provide eCTD services for regulatory compliance.

The Challenge

The primary challenge is to conduct a comprehensive review of the client’s existing documents and FDA registrations to assess the language and claims currently associated with the product. Based on this review, we will devise a strategy to enhance the claims and explore new possibilities for marketing, professional communication, and packaging design.

The Approach

  • Claims Substantiation Review: We will meticulously analyze the client’s existing documents and FDA filings to understand the current claims associated with the product. Through a rigorous evaluation process, we will identify opportunities for improvement and expansion of claims.
  • Marketing Communication Strategy: Based on the review, we will provide strategic counsel and guidance to the client on language that can be effectively utilized in their marketing communication efforts. This will encompass advertising, promotional materials, and website content. Our goal is to craft compelling messaging that resonates with the target consumers while ensuring compliance with regulatory requirements.
  • Package Design Guidance: Our team will also offer strategic input on language to be incorporated into the package design. By aligning the packaging with the product’s claims and positioning, we will help the client create an impactful and attractive packaging design that stands out in the competitive OTC marketplace.
  • eCTD Services: Ensuring regulatory compliance is essential for the client’s success in the OTC market. We will provide Electronic Common Technical Document (eCTD) services to streamline and facilitate the submission of necessary documents to the FDA. Our expertise in eCTD will expedite the regulatory approval process and save valuable time and resources for the client.

The Outcome

Following our engagement, Lumanity delivered a comprehensive plan to the client, outlining recommended label claims and substantiation. Our team provided expert guidance on language for marketing communication, advertising, and promotional materials, as well as website content. Additionally, we assisted the client in crafting responses to FDA’s information requests, ensuring effective communication with the regulatory authority. Overall, our strategic input and eCTD services empowered the client to optimize their product’s claims, enhance marketing efforts, and achieve regulatory compliance, leading to a successful market launch and increased consumer engagement.

Contact us

If you would like to find out more about the regulatory support we can offer, please contact us.