Consulting

Our regulatory guidance and product development advice shed light on the best route to approval.

Our regulatory guidance and product development advice shed light on the best route to approval.

The regulatory process is distinct and intricate in the U.S., Canada, U.K., Europe, and elsewhere, and we’re here to collaborate with your team on meeting these global requirements. Decades of interactions have established our reputation with regulatory agencies and strengthened our knowledge of the most efficient ways to help you reach successful outcomes.

Our consultants round out our clinical support with services that position your therapy for IND, IMP, or equivalent status, and product development guidance for marketing approval and beyond.

Our regulatory and product development experience runs deep in the pharmaceutical, medical device, and biotechnology industries, so we can be an asset to your team with any kind of therapeutic innovation.

 

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Clinical Strategy

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Nonclinical

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Chemistry, Manufacturing, and Controls (CMC)

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Regulatory Affairs

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GxP Consulting

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Publishing and Submissions

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Medical Writing

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