Certara Announces FDA Renewal and Expansion of Certara’s Biosimulation Software for Reviewing Regulatory Submissions
21 déc. 2021 08h00 HE
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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
23 juin 2021 19h00 HE
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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
25 avr. 2017 07h30 HE
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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
01 févr. 2017 10h00 HE
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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
19 janv. 2017 07h44 HE
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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
09 nov. 2016 08h17 HE
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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
23 août 2016 08h17 HE
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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...