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Category Archives: COVID19

Improving Investigations: An Inspector’s Perspective

Facility inspections continue to be on the minds of both drug manufacturers and regulators. Over the past year, we’ve discussed the challenges surrounding inspections in our Maintaining Quality and Supply…

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Pharma Trends for 2021

After 2020, trying to predict anything at all seems a bit reckless. Most of us are still trying to wrap our heads around last year — and hoping this year…

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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…

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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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API Industry Faces Challenges and Opportunities

The global market for active pharmaceutical ingredients (APIs) is expected to grow at a 3–6% Compound Annual Growth Rate (CAGR) over the next five years, exceeding U.S. $1.5 trillion by…

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While the U.S. Worries Over Supply Chains, India Seeks Solutions: Atmanirbhar Bharat

Starting in March, PPE – personal protective equipment, including gloves, gowns and face masks – became as valuable as gold…and nearly as rare. During a media briefing on March 27,…

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Pharma Manufacturing Operations in the Time of COVID-19

There has been a flood of articles recently on how companies have adapted to our new reality in a coronavirus-affected world. As an essential services manufacturer and lab, Neuland has…

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