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Pharmapprove team spotlight

Team Spotlight: Dr. Steffen Thirstrup

Steffen is one of NDA Groups's experts on Oral Explanations. Prior to joining NDA seven years ago, Steffen spent nine years as the Chief Medical Officer and Head of Division at the Danish Medicines Agency. During five of those he also acted as the...
Drug Development Communications with Regulatory Agencies

Importance of Excellence in Scientific and Regulatory Communications

A number of potential pitfalls await companies with even the most solid science and robust datasets.
FDA Pre-Submission Support

Proactive planning and communication with FDA is critical to regulatory success

It’s common knowledge that communicating early and regularly with the FDA is critical to regulatory success.

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