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Regulatory Publishing Expertise for an Efficient NDA Submission Process

Veristat supported a commercial stage biopharmaceutical company in NDA submission, bringing regulatory publishing expertise for a new therapy being developed for the acute treatment of schizophrenia or bipolar disorder-associated agitation. This...

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Early Development Challenges in IND Applications

There is much for companies to consider before submitting an investigational new drug (IND) application to FDA. Planning, collecting the appropriate data, and effectively communicating with regulatory bodies can all help companies overcome challenges in...

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4 min read

Regulatory Guidance Monthly Review - August 2022

Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA)  that are pertinent to the governance of clinical trials and drug, biologic, or medical device...

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