News : 20 Aug 2019

August 20, 2019 | FDA to Close Public Consultation on ICH M10 Bioanalytical Method Validation

The US Food and Drug Administration (FDA) public consultation of the International Council for Harmonisation (ICH) draft guideline, M10 Bioanalytical…

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News : 16 Apr 2019

April 16, 2019 | Kneat Launches Annual ‘Customer Summit’ to Enable Customer-Driven Development

HALIFAX, April 16, 2019/– Kneat is pleased to announce the launch of the inaugural Kneat Customer Summit, the first in…

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News : 28 Feb 2019

February 28, 2019 | FDA’s New Continuous Manufacturing Guidance Carries Process Validation Implications

In a new 27-page Guidance, ‘Quality Considerations for Continuous Manufacturing’, released February 27, 2019, the FDA and CDER (Center for…

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News : 24 Jan 2019

January 24, 2019 | FDA Release New Method Validation Guidance

Finalizing a draft guidance first issued in April 2016, the FDA have this week released a new final guidance for…

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News : 20 Dec 2018

December 20, 2018 | FDA Release New Data Integrity Guidance

Data Integrity remains a key focus for the FDA in 2018, now five years on since the subject was first…

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