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EU GDP Guidelines: Implications for Shipping Clinical Materials into the European Market

Recently, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) opened an investigation into a patient complaint of mold on paracetamol (acetaminophen) tablets (1). It discovered the product was shipped by sea from India to multiple companies in the UK at temperatures reaching up to 60 degrees Celsius. Labeling for paracetamol tablets typically states they should be kept below 30 degrees Celsius. In addition, MHRA discovered the humidity levels exceeded 80 percent during shipping, which is too high for the packaging that was used.
EU GDP Guidelines: Implications for Shipping Clinical Materials into the European Market
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News and Press Releases

Cytel expansion unlocks innovative clinical development expertise for APAC biopharma sector

Waltham, MA, September 06, 2022 – Cytel Inc., a pioneer of adaptive clinical trial design and provider of advanced biometrics services, has expanded its operations into the Asia-Pacific region (APAC). This enables biotech and biopharma companies in APAC to have easier access to Cytel’s established biometrics and advanced statistical solutions. For more than 35 years, Cytel has pioneered innovative adaptive clinical trial designs and a suite of validated statistical and predictive software platforms. Cytel has also successfully supported sponsors in all aspects of innovative clinical trials, from statistical design to implementation and regulatory acceptance, helping them reduce costs, shorten timelines, and better unlock the value of their data.
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White Papers

galenIQ - The smart excipient

BENEO GmbH

galenIQ combines a multitude of outstanding characteristics and is suitable for a wide range of pharmaceutical applications. galenIQ can be used as more than just a bulk excipient. It also serves as an anti-caking agent, anti-humectant agent, stabilizer or oral care and taste agent to mention just a few additional functions.
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