A leader in the pharmaceutical industry wanted to leverage real-world evidence to bolster the claims of an over the counter (OTC) product in the E.U. and U.S. markets.
Indeed, as researchers collect real-world evidence, they can examine variables previously unaccounted for in early trial phases such as smoking and drinking, allowing them to gain a deeper understanding of how such factors impact the study product.
The client, recognizing the emergence of guidelines on the proper use of real-world evidence for claims support in both markets, wanted to ensure their adherence to new regulation when using the evidence to substantiate their product’s claims.
Our client needed help with the claim substantiation of one of its over the counter product via real-world evidence and the validation of a clinical trial strategy.
Our regulatory experts’ effort, combined with our proprietary automated technology, allowed us to give them in less than three weeks all the regulatory insight on claim substantiation with real-world evidence they needed to decide how to approach choosing a solid clinical strategy.
RegASK is here to help you quickly find the proper regulatory insight for your products’ entry into any market around the world.
Navigate complex regulatory terrain even when the map keeps changing.
Our team of regulatory experts leverages artificial intelligence technology to provide.
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From the smallest markets to major cities, RegASK experts have the nuanced expertise you need.
Our regulatory experts have extensive experience working with domestic authorities in developing countries and understand the processes involved in each market to ensure compliance and successful market entry throughout your product lifecycle.
Our experts leverage our technology to provide answers in a cost-efficient and swift manner, guiding you in making informed decisions and developing optimal regulatory strategies.