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Key to Outsourcing Method Development and Validation A Pragmatic Approach

In an industry that is seeing an increasing level of work being outsourced, the Contract Research Organisation (CRO) of choice needs to have proven experience in both the pragmatism and flexibility of the method developerís mind set and a regulatory background in validation.
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News and Press Releases

PCIís Tredegar Site Announces Significant Expansion of Analytical Laboratories at its Center of Excellence for Contained Manufacturing

Philadelphia, USA- March 19, 2018. Global pharmaceutical outsourcing services provider PCI Pharma Services (PCI) is pleased to announce a laboratory expansion at its site in Tredegar, Wales, UK. 
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White Papers

Pharmacovigilance and Risk Management Information in Centralised Applications in the EU

United BioSource Corporation (UBC)

Getting a new medication approved for the EU market through the centralised procedure can be complex and needs expertise. The new EU pharmacovigilance legislation (Good Vigilance Practice, GVP) is now in effect and applicants need to be fully compliant. It is critical to have a thorough understanding of the regulatory process and requirements, and the expectations with regards to the pharmacovigilance system and the risk management plan. Ensuring consistency and an appropriate level of detail in the documentation submitted as part of the approval process will help prevent unnecessary delays.
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Industry Events

Vaccine Manufacturing

23-25 April 2018, RAI, Amsterdam

Changing the shape of vaccine development, manufacturing and delivery.
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