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Volume 13 Issue 4

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, w...
24 November 2021 Volume 13 Issue 4 Abzena | CDMO
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Volume 13 Issue 4

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 backlog of FDA inspect...
24 November 2021 Volume 13 Issue 4 FDA | FDA Remote Inspections
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Volume 13 Issue 4

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 ha...
24 November 2021 Volume 13 Issue 4 IVDR legislation | labelling
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Volume 13 Issue 4

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, independ...
24 November 2021 Volume 13 Issue 4 COVID-19 vaccine | drug development
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Volume 13 Issue 4

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...
24 November 2021 Volume 13 Issue 4 FDA | FDA Compliant
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Volume 13 Issue 4

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 we have ente...
24 November 2021 Volume 13 Issue 4 COVID-19 | drug development
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Volume 13 Issue 4

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, i...
24 November 2021 Volume 13 Issue 4 Coated Pellets | hard gelatine capsule
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Volume 13 Issue 4

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 research among...
24 November 2021 Volume 13 Issue 4 automating | life sciences
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Volume 13 Issue 4

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 comple...
24 November 2021 Volume 13 Issue 4 COVID-19 | disruptive technologies in life sciences
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Volume 13 Issue 4

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...
24 November 2021 Volume 13 Issue 4 IMDRF | innovators
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