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Case Studies

Regulatory Expertise Eases the Way for Company’s First IND Submission

A young biopharmaceutical company developing a pipe-line of preclinical cancer immunotherapy treatments was preparing to file its first investigational new drug (IND) application with the…

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Articles

Compliance Issues? First, Don’t Panic

Abstract: Meeting compliance issues is like preparing for a hurricane: both situations require making sure that everything is nailed down well before the storm hits.…

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Case Studies

Successful Medical Device Design Transfer Lifts One of the Largest FDA Mandates in History

Project Background A global manufacturer received an FDA mandate on one of its medical devices to repair, retire, or replace all units (more than 200,000)…

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Case Studies

Coordination Secures On-Time Biopharmaceutical NDA Submission and Launch

Project Background A major pharmaceutical company in-licensed a developmental pharmaceutical product nearing the end of Phase III clinical trials. At the time, the previous owner…

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