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September 24, 2024 08:00 ET | Source: Certara

Certara’s Simcyp Consortium Celebrates 25th Anniversary

Certara, a global leader in model-informed drug development, today announced the celebration of the 25th anniversary of the Simcyp® Consortium.
December 21, 2021 08:00 ET | Source: Certara

Certara Announces FDA Renewal and Expansion of Certara’s Biosimulation Software for Reviewing Regulatory Submissions

PRINCETON, N.J., Dec. 21, 2021 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that the U.S. Food and Drug Administration (FDA) has renewed and...
June 23, 2021 19:00 ET | Source: Certara

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) Renews Licenses of Certara’s Biosimulation Software for Evaluating Regulatory Submissions

PRINCETON, N.J., June 23, 2021 (GLOBE NEWSWIRE) -- Certara, a global leader in biosimulation, today announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has renewed its...
April 25, 2017 07:30 ET | Source: Cutting Edge Information

Half of Pharma Global Teams' Pharmacovigilance Funding is Contributed by a Standalone Drug Safety Team

RESEARCH TRIANGLE PARK, NC--(Marketwired - April 25, 2017) - On average, half (50%) of surveyed global teams' pharmacovigilance funding is contributed by a standalone drug safety team, according to...
February 01, 2017 10:00 ET | Source: Nuvectra

Nuvectra Files Regulatory Submissions for FDA and CE Mark Approvals of the Virtis™ Sacral Nerve Stimulation (SNS) System

PLANO, Texas, Feb. 01, 2017 (GLOBE NEWSWIRE) -- Nuvectra Corporation (NASDAQ:NVTR), a neurostimulation medical device company, announced today that it has filed regulatory submissions with the U.S....
January 19, 2017 07:44 ET | Source: Cutting Edge Information

70% of Global Drug Safety Teams Outsource Case Management Activities

RESEARCH TRIANGLE PARK, NC--(Marketwired - January 19, 2017) - Data published by pharmaceutical competitive intelligence firm Cutting Edge Information found that literature services are the most...
November 09, 2016 08:17 ET | Source: Cutting Edge Information

These Three Resources are What 80% of the Pharmaceutical Industry Relies on for Pharmacovigilance and Drug Safety Data

RESEARCH TRIANGLE PARK, NC--(Marketwired - November 09, 2016) - Individual case safety reports (ICRs), global safety databases and external literature are the top sources of drug safety information...
August 23, 2016 08:17 ET | Source: Cutting Edge Information

Pharma Companies Consider Number of ICSRs Received per Month the Most Important Outsourcing Factor

RESEARCH TRIANGLE PARK, NC--(Marketwired - August 23, 2016) - Among post-launch pharmacovigilance activities, the number of individual case safety reports (ICSRs) that a drug company receives each...