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How to proceed with an active ingredient that can be effective...

Although numerous clinical trials are underway, there is currently no evidence from controlled clinical trials to recommend...

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Accessing the European Pharma Market: becoming a MAH through...

Positioned as the second largest pharmaceutical market in the world and showing a steady and extensive growth pattern, Europe’s...

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Biotechnology: Incentives of the Advanced Medicinal Products...

What are Advanced Therapies? Advanced-therapy medicines are medicines that are made from genes and cells. They may offer...

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Accessing the EU Market: Becoming a suitable CMO for Europe...

In recent years, the volume of generic drug sales has been increasing rapidly in Europe, whereas the outsourcing of branded...

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Safety Reports: The importance of high quality content from...

The action plan developed by the AEMPS and published April 2016 focuses on the set up of specific activities, such as the...

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Accessing the European Pharma Market: becoming a MAH through...

The European pharma market is becoming more competitive and accessible through its effort to adopt globally acknowledged...

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Brexit: Regulatory Impact

On 29 March 2017, the United Kingdom notified the European Council of its intention to withdraw from the European Union,...

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