Regulatory Resources

This new white paper is designed to provide an overview of the recently introduced EU Guidelines on the Good Distribution Practice (GDP) of Medicinal Products for Human Use and the significant new dem...

Biologics companies face a unique paradox. Inconsistent regulations surrounding their in-transit production one hand, and a Byzantine shipping process on the other, result in clinical delays, and ulti...

Time is ticking for China’s pharmaceutical and logistics companies to modernise and comply with the new Good Supply Practice (GSP) regulations. Yet this is easier said than done due to the complexity...

For long years pharmaceutical industry in Russia has been awaiting implementation of GxP-practices as a legally binding requirement. Start was given at the end of 2013 when GMP was officially put in f...

Richard Coe, GDP Responsible Person, Xellia Pharmaceuticals, discusses Xellia’s supplier relationship management project, how supplier partners play an essential role in effective GDP implementation a...

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In previous articles we have stressed the importance of supplier qualification, with a special focus on logistic service providers. As we are aware of the immediate impact on quality, controlling it t...

Your Roadmap to Success!The serialisation strategy of a company and the resultant serialisation service that delivers and maintains the capabilities required, needs to ensure that the requirements of...

With over 500 participants from hundreds of different pharmaceutical manufacturers, leading solution providers and cold chain logistics experts, Cool Chain & Temperature Controlled Logistics Europ...

Ahead of the Global Forum, Cold Chain IQ takes a closer look at key trends in the global cold chain management, from reducing complexity and cost to greener cold chain solutions. The Global Cold Chain...

Understanding pharmaceutical legislation is vital for successfully navigating the complex global clinical trials market and ensuring the timely supply of your Investigational Medicinal Products (IMPs)...

Good Distribution Practice (GDP) is the part of quality assurance which ensures that products are consistently stored, transported and handled under suitable condition as required by the marketing aut...