Case Study 157: IND Submission to US FDA for a New Chemical Entity for the Treatment of Gout

Company Situation

The client has developed a new drug, class 1 new chemical drug as per classification in China and was planning to submit the IND in China. They also intended to file an IND in USA in parallel as part of their global drug development strategy. Since they did not have a presence in the US and they sought an expert with experience in US FDA for drug development clinical and regulatory affairs.  

GRP Solution

GRP’s US based team has over three decades of experience in successfully obtaining IND and NDA approvals for new drugs. Using its experience working with FDA and that of working in China, GRP’s global team is helping the client chart out its global drug development strategy and spearhead its clinical development and regulatory strategy in the USA.

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