Certara Announces FDA Renewal and Expansion of Certara’s Biosimulation Software for Reviewing Regulatory Submissions
December 21, 2021 08:00 ET
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Certara
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...
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) Renews Licenses of Certara’s Biosimulation Software for Evaluating Regulatory Submissions
June 23, 2021 19:00 ET
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Certara
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...
Half of Pharma Global Teams' Pharmacovigilance Funding is Contributed by a Standalone Drug Safety Team
April 25, 2017 07:30 ET
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Cutting Edge Information
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...
Nuvectra Files Regulatory Submissions for FDA and CE Mark Approvals of the Virtis™ Sacral Nerve Stimulation (SNS) System
February 01, 2017 10:00 ET
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Nuvectra
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....
70% of Global Drug Safety Teams Outsource Case Management Activities
January 19, 2017 07:44 ET
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Cutting Edge Information
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...
These Three Resources are What 80% of the Pharmaceutical Industry Relies on for Pharmacovigilance and Drug Safety Data
November 09, 2016 08:17 ET
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Cutting Edge Information
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...
Pharma Companies Consider Number of ICSRs Received per Month the Most Important Outsourcing Factor
August 23, 2016 08:17 ET
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Cutting Edge Information
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...