How Real-World Evidence Supported Claim Substantiation on OTC Product in Europe and the USA

Post How Real World Evidence Supported Claim Substantiation On Otc Product In Europe And Usa

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.


What’s The Problem?

The client needed to get an overview of the regulations related to the usage of real-world evidence

  • To evaluate the feasibility and requirements for particular claim substantiation
  • To foster a greater understanding of relevant requirements
  • And adhere to novel regulatory guidelines on real-world evidence use to substantiate new claims or strengthen existing indications


What We Did

RegASK proposed a fast-response solution by leveraging its global network of regulatory experts and proprietary automated technology, and

  • Identified requirements in the E.U. and U.S. markets
  • Evaluated the desired claims to estimate the likelihood of substantiation via real-world evidence
  • And recommended a forward-thinking strategy for each market


How Did It Do?

RegASK delivered a clear regulatory overview of real-world claim substantiation in less than three weeks.

The client was able to make appropriate and efficient decisions with their claim substantiation and pinpoint a sound clinical trial strategy in the E.U. and U.S. markets.



Our client needed help with the claim substantiation of one of its OTC products 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.

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