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Veristat Supported Marketing Applications for 10% of all FDA Novel Drug Approvals in 2020

Strengthening its Track Record of Successful Client Regulatory Approval Outcomes

SOUTHBOROUGH, MA – January 14, 2021 – Veristat, a scientific-minded global clinical research organization (CRO), announced today that they supported the marketing applications for 10% of the 2020 US Food and Drug Administration (FDA) novel drug approvals. The FDA approved 53 novel drugs, defined by the FDA as New Molecular Entities (NMEs)[i], and Veristat regulatory, statistical, and medical writing experts were integral in preparing five of these NME New Drug Applications. Veristat also prepared NDA/BLAs for three non-NME FDA approvals and one Marketing Authorization Application (MAA) that received approval in Europe.

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Veristat Strengthens Its Regulatory Expertise with the Acquisition of Catalyst Regulatory Services

Expanding Its Team of Regulatory Experts to Guide Biopharmaceutical Sponsors
 Along the Pathway to Market Approval

 

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Veristat Supports 12% of all FDA NME Approvals in 2018, a Record-Setting Year for FDA Approvals

Veristat Celebrates Its Support of over 75 Global Regulatory Submissions Since Its Founding

 

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Veristat Supports Antibe Therapeutics for Pain and Inflammation Study

Upon receiving approval from Health Canada, Antibe Therapeutics selected Veristat to immediately begin work on part one of a Phase 2B dose-ranging, efficacy study for their lead drug candidate ATB-346.   The study will run in Canada and is expected to conclude in December 2018.

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