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Category: Regulatory Management

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...

Why a CDMO Might Be the Best Place to Find Regulatory Support

May 02, 2021

The main goal for any drug company is achieving a speedy path to market. While many obstacles threaten...

2 Key Factors to Accelerate Drug Approvals: Expertise and Relationships

December 29, 2020

Drug approvals are often complex and time-consuming, even for generic versions of approved medications....

LGM Helps Pharma Manage Supply Chain Risks with Added Services Through Nexgen Acquisition

November 02, 2020

COVID-19 has put supply chain risk management practices under the microscope. Coming on the heels of...

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