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Economic Nationalism or Global Cooperation? How About a “Thank You,” Instead?

I saw this lede for an article (Bio/Pharma, People, Perseverance, and Hope) about 2020 by Rita Peters at PharmTech and smiled. It captured the state of life sciences this past…

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Update on Regulatory Guidance for Facility Inspections

During the initial outbreak of the COVID-19 pandemic, travel and social distancing restrictions had a significant impact on regulatory inspections. In March of 2020, hands-off policies quickly became the new…

Posted in APIs, audit, Chemistry, CMC, COVID19, CRO/CMO, FDA, Industry news, Neuland Labs, QA/QC, Quality, regulatory | Tagged , , , , | Comments Off on Update on Regulatory Guidance for Facility Inspections

Maintaining Quality and Supply During COVID-19

The need for API manufacturers to establish strong quality systems and plan for business continuity has never been greater than it is today. And you can probably guess the reason…

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The Need for Speed: Drug Development, Trials & Regulatory Pathways Accelerate in the Wake of COVID-19

For drug makers, speed has always mattered. Every day a drug is delayed on the path to market costs pharma companies millions of dollars. Delays can also lead to the…

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Pharma Drug Innovation in 2020: From Novel Drugs to Drugs for Novel Coronavirus

Have other areas in drug discovery suffered because of COVID-19? It’s probably not too early to say that COVID-19 has changed pharmaceutical drug discovery considerably. And why wouldn’t it have,…

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Beyond COVID-19: What Else in Happening in Pharma?

Around the world, pharma and biopharma – along with all of the supporting industries, from suppliers and research organizations to outsourced providers – have been exclusively focused on COVID-19. With…

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On-Site Pharma Audits During the Coronavirus (COVID-19) Crisis

The outbreak of COVID-19 has significantly impacted physical visits to drug manufacturing facilities. This raises a number of challenges, since many regulations — especially those relating to inspections — weren’t written with…

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