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The September issue of RF Quarterly, a publication of the Regulatory Affairs Professionals Society (RAPS), features two articles authored by regulatory experts at Integrated Project…
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“How can we submit sooner?” It’s long been the most common question a regulatory submissions team hears. Executive leaders have ambitious goals in mind for…
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There’s an adage that says what gets measured gets improved. Regulatory submissions are no exception. And with the growing complexity of clinical trials and increasing…
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Development of a novel therapeutic takes several years of intense research and detailed planning. Because target populations are likely to be distributed over multiple regions…