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Regulatory Strategy

At CTI, we understand that a regulatory strategy should consider critical regulatory and therapeutic information, as well as evaluate the unique characteristics of each product to devise a realistic and effective strategy.  We have the ability to bridge the gap between strategy and execution.  Our team of multidisciplinary drug and device development professionals, including international regulatory and medical experts, rely on past drug development experience, previous interactions with regulatory authorities, tenure serving on regulatory committees as reviewers, and current data in the public domain to support our sponsors' programs. We have a history of more than 100 drug and device approvals. Choosing CTI as a partner for strategic regulatory needs adds value to programs by developing realistic plans and strategies that efficiently move programs forward. 

Clinical Development Planning

Our flexible staff is accustomed to partnering with our sponsors to develop plans that are not only sound from a regulatory perspective, but also take into consideration the goals of your organization.

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Interactions with Regulatory Authorities

Our relationships with key regulatory officials help to facilitate communication and build on expectations of quality products that are scientifically sound and clearly presented.

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Regulatory Strategy & Consulting

CTI has a team of dedicated professionals with more than 30 years in regulatory, clinical, and management experience, including former US Food and Drug Administration (FDA) committee members and individuals with European Medicines Association (EMA) expertise.

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