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Agency meetings

Would holding a pre-IND meeting with FDA decrease the likelihood of clinical hold?

Our Regulatory Consulting and Submissions group can answer that question for you. They are experienced in requesting and conducting meetings with regulatory agencies around the globe, providing you with valuable input to strategies for a successful program, and saving time and money.

With Regulatory Consulting and Submissions staff in Australia, Mexico, the United Kingdom and the United States, Kendle has experience in a wide range of regulatory submissions activities in all major regions of the globe. This experience allows us to offer you a comprehensive, targeted approach when submitting to various agencies. In fact, many members of our staff possess both regulatory agency and pharmaceutical industry experience.

Read more about our regualtory advice expertise