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| home > white papers > Key to Outsourcing Method Development and Validation A Pragmatic Approach - RSSL |
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 WHITE PAPERS |
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RSSL
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+44 (0)118 918 4024
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http://www.rssl.com
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University of Reading, Whiteknights Rd, Reading, West Berkshire RG6 6LA
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Key to Outsourcing Method Development and Validation A Pragmatic Approach
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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 developer’s mind set and a regulatory background in validation.
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News and Press Releases |
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PCI’s 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 |
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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 |
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Vaccine Manufacturing
23-25 April 2018, RAI, Amsterdam
Changing the shape of vaccine development,
manufacturing and delivery.
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