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EU Clinical Trial Regulation: Investigational Medicinal Product Labeling
In this blog post, Gemma Puckey, senior manager of regulatory affairs, explains the impact of the European Union (EU) Clinical Trial Regulation (CTR) 536/2014, specifically Annex VI, on labelling of Investigational Medicinal Products (IMPs).
Global Clinical Supplies
Our team provides complete life-cycle management
FSP Global Clinical Supplies
PPD FSP global clinical supplies solutions help biotech, biopharmaceutical and medical device companies optimize clinical trial supplies lifecycle.
Regulatory Insights: ‘Right First Time’ Approach to Post-Authorization Strategy
Proactive post-authorization regulatory requirements intelligence is essential in the pharmaceutical industry. Learn about regulatory authority requirements.
Drug Discovery and Development Process
The drug discovery and development process is long but can result in new life-saving treatments and therapeutics.