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PBOA Members Committed To Continuing To Reliably Manufacture Drug and Vaccine Products

The Pharma & Biopharma Outsourcing Association (PBOA), a trade group that represents Contract Manufacturing Organizations (CMOs) and other service providers in the bio/pharmaceutical sector, reports that its member companies remain committed to serving patients by manufacturing effective, quality products...

Alembic Pharma receives 4 observations from USFDA for Panelav facility

Alembic Pharmaceuticals on Monday said that US health regulator has conducted an inspection at it Panelav facility in Gujarat and issued Form 483 with four procedural observations. "The US Food and Drug Administration (USFDA) has conducted an inspection at Alembic...

Roches cobas SARS-CoV-2 Test to detect novel coronavirus receives FDA Emergency Use Authorization

Roche announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the cobas® SARS-CoV-2 Test. It is intended for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19 disease, in nasopharyngeal...

Clinerion received ISO 27001:2013 certification

Clinerion has gained ISO 27001:2013 certification, the international standard that describes best practice for an information security management system (ISMS). ISO 27001:2013 is a standard set by the International Organization for Standardization (ISO), the independent, non-governmental international organization of national...

COVID-19 and the pharma supply chain – How to manage your pharmaceutical logistics in difficult times

With panic buying of face masks and no hand sanitiser on chemists’ shelves, there is no doubt that the latest COVID-19 outbreak is having a global effect. Schools are closing, conferences and sporting events are being cancelled… it is...

Sinclair Research Announces Toxicology Laboratory Expansion

Sinclair Research, a leading provider of nonclinical contract research services, will officially open its 20,000-square-foot laboratory expansion later this spring. The additional capacity will support GLP nonclinical toxicology research studies to meet the growing demand from pharmaceutical customers for...

FDA Issues Emergency Use Authorization to Thermo Fisher Scientific for Diagnostic Test Used to Detect COVID-19

Thermo Fisher Scientific Inc., the world leader in serving science, announced that the U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for its diagnostic test that can be used immediately by CLIA high-complexity laboratories...

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