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How to Coordinate Your Site Selection With State Economic Development

Where are your labs located? Development/pilot/clinical material facilities? Commercial plants? If these do not exist, where should you build them? If outsourcing, where are your …

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Preparing for FDA Remote Inspections: What to Expect for 2022

If there’s one thing 2020 taught the world, it’s that the road ahead is ever-changing. Given the Delta variant on the rise and the significant …

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The New Regulatory World for Medical Devices

Establishing an Effective Compliance Strategy Now Ahead of the 2022 IVDR legislation – Because There’s More to Come No sooner than medical device manufacturers have …

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Hyper-collaboration in Healthcare and Life Sciences – The New Paradigm

The COVID-19 pandemic demonstrated the ability of the healthcare and life science industry to respond to unexpected needs with unprecedented speed. However, independent of the …

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It’s Now Time for Your OPDP Submissions to be FDA Compliant | Are You Ready?

The Prescribing Information, Labeling, and any other materials used for the promotion of Drug Products for their approved indication, or intended purpose of use, are …

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The Brave New World of Rapid Drug Development

The COVID-19 pandemic has brought the topic of rapid drug development to the forefront of the life sciences sector. Ray Chohan at PatSnap, believes that …

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Evaluation of an Alternative Solid Dosage Form to Enteric Coated Pellets Containing Ibuprofen: A Case Study

Recent works have evaluated the potential of minitablets contained in hard gelatine capsules. To get the benefits and advantages of multi particulate dosage forms, it …

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Quality Overtakes Cost as the Priority as Life Sciences Companies Move to Automate Pharmacovigilance Case Intake

For the first time, quality has overtaken cost as a priority in plans for automating adverse event (AE) reporting. These are the findings of brand-new …

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The New Normal: How COVID-19 Became the Catalyst for Change

When COVID-19 disrupted life sciences, solutions were needed in real-time. As the pandemic grew, so did the need to innovate. Workers met the challenges. They …

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Defining and Regulating the Complex World of Software as a Medical Device

The medical devices landscape has changed dramatically in recent years with the shift from hardware-based medical devices to the advent of smart, standalone software technology …

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