Veristat Congratulates Origin Biosciences for FDA Approval of Nulibry during the Week of Rare Disease Day 2021
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.
Accelerating cell and gene therapy opportunities for patients by advancing access to knowledge and leveraging experience for sponsors to increase program success
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SOUTHBOROUGH, MA – October 22, 2020 – Cell and gene therapies represent the next great wave of therapeutic innovation and have led to the development of promising therapies worldwide.
Increasing Its Footprint and Expanding Therapeutic Expertise to Guide Sponsors Throughout the Clinical Development Lifecycle
Expanding Its Team of Regulatory Experts to Guide Biopharmaceutical Sponsors Along the Pathway to Market Approval
Veristat Celebrates Its Support of over 75 Global Regulatory Submissions Since Its Founding
Expanding Its Clinical Operations and Biometrics Teams Dedicated to Emerging, Small and Mid-Sized Biopharma
Continues Collaboration to Provide Regulatory Submission Support for
Additional Patisiran Submissions
SOUTHBOROUGH, MA – August 20, 2018 – Veristat, a full service Clinical Research Organization (CRO), congratulates Alnylam on the recent FDA approval of ONPATTRO™ (patisiran), a lipid complex injection for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults.