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Practical notes on regulation, quality systems, clinical operations, and life sciences consulting.

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Contract and Consulting Support in the Life Sciences Industry

Why life science companies hire contractors, and how flexible resourcing supports temporary demand without permanent cost.

December 5, 20224 min read

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Nov 29, 2022

483 Warning Letters & How to Resolve Them

What an FDA 483 Warning Letter is, and how to work through the findings behind it.

Read article Jul 26, 2022

3D Printing of Medical Devices

How 3D printing met urgent PPE demand during COVID-19, and what that means for medical device regulation.

Read article Jan 27, 2022

Compounding, Outsourcing Facilities, Current Good Manufacturing

How compounded drugs and outsourcing facilities are regulated under federal manufacturing rules.

Read article Nov 29, 2021

FDA Oversight for Medical Devices: Insight into Regulatory Process

How the FDA regulates medical devices from development through commercial use.

Read article Sep 26, 2021

Pharmacovigilance, Then and Now

How pharmacovigilance grew from early ADR reports into today's clinical and post-market safety work.

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