R&D: Regulatory


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Now more than ever, global health authorities are looking for a comprehensive risk management plan that includes not only all of the elements of regulatory compliance, but ties to the company’s plan for sales, marketing, and overall brand protection, our experts say.
“Deeper involvement by the regulatory professionals in the overall product launch strategy earlier in the development stages of the product helps pharmaceutical companies demonstrate to health authorities their commitment to the safety of consumers, affording a better chance at a smooth registration process,” says Michael O’Gorman, CEO of Sentrx.

Results of PDUFA IV
European Regulations