Regulatory & Access: Local knowledge

July 17, 2020

Parexel’s +1000 consultants, including ~100 former regulators / HTA assessors have helped to develop guidance across the world. They not only have the global expertise but also the local know-how to help biopharmaceutical companies navigate regulatory and market access hurdles. Learn more https://www.parexel.com/solutions/consulting #regulatory #market access

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Has EMA started a domino effect for more regulation of API manufacturing?
Has EMA started a domino effect for more regulation of API manufacturing?

On June 23, 2020 the European Medicines Agency (EMA) released a report on lessons learned from the presence...

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What’s Around the Corner for FDA Inspections?
What’s Around the Corner for FDA Inspections?

There have been two recent activities from the U.S. Food and Drug Administration (FDA) that provide industr...