PREA Requirements, and Why You Can’t Afford to Ignore Them

Pediatric regulation consulting that saves time and money

There’s nothing easy about pediatric regulations — starting with the fact that regulations in the U.S. (PREA) and the European Union (PIP) often require pediatric trials for adult medicines.

Because of the confusion, many sponsors fail to meet the requirements, prompting the FDA to issue a non-compliance letter, make the letter public, and cause numerous delays and extra costs.

Our pediatric specialists can guide you through this minefield, save you time and money, and perhaps win you a postponement — or even an exemption from the requirement.

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