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Category: Regulatory Support

What You Need to Know About Post-Approval Change Pathways

April 01, 2023

Post-approval changes (PACs) – changes made to the drug substance manufacturing process after receiving...

Preparing for DSCSA Track and Trace Implementation

September 30, 2022

Counterfeit drugs have become big business. In 2019, it was estimated that $200 billion worth of counterfeit...

Analytical Testing for Drug Development

November 01, 2021

How do you ensure that your active pharmaceutical ingredients, their starting materials and intermediates,...

How to Stay Compliant in a Changing Pharma Regulatory Landscape

December 06, 2019

In 2012, contaminated medications from the New England Compounding Center (NECC) caused a meningitis...

Understanding 505(b)(2) Drug Development & API Supply Issues

November 04, 2019

Situated between the NDA and the ANDA is an increasingly popular drug commercialization pathway – the...

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