CLINICAL SUPPLY REGULATORY ARTICLES
Warning To U.S.-Based CDMOs: Don't Get Complacent
How could I not ask him for an opinion regarding our vigorously pursued editorials on the WuXi Apptec–BIOSECURE Act. After all, Reza Oliyai has outsourced a myriad of development and manufacturing services to hundreds of CDMOs around the world. He did so at Gilead for decades, and since as the CEO of his eponymous consulting company. His response did not disappoint.
CLINICAL SUPPLY REGULATORY VIDEOS
Succeed in combination product development by understanding the risk factors that may arise and implementing mitigation strategies that will streamline the device development process.
Decentralized clinical trials are made up of a multitude of elements, from in home clinical capabilities, logistics, digital platforms, and technology, to global reach and more. This webinar shares important factors to consider to build your DCT ‘molecule’ successfully.
Understand how free trade zones work, and explore a flexible and cost efficient way to supply clinical trials in China and around the globe.
In the era of seamless development, reducing time to the clinic and getting rapid approval is key. An integrated approach can accelerate timelines, avoid communication pitfalls, and improve outcomes.
CLINICAL SUPPLY REGULATORY RESOURCES
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![GettyImages-1333159166-cold-chain-shipping-logistics-transportation]( "Overcoming Obstacles To Deliver Critical Autologous Cell Therapy")
See how teams ensured a seamless route, including on-time customs clearance and delivery of autologous cell therapy, from the U.S. to a manufacturing site in Germany
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![Warehouse Boxes]( "Trade Compliance: Challenges In Global Biopharma Materials Logistics")
Have you noticed that it has become increasingly difficult to transport your material into and out of the United States? That’s because it has!
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![GettyImages-184945838-cold-chain-cryopreservation]( "Cold Chain Shipping Considerations: Understanding Passive Shippers")
Learn more about the design and performance of passive shippers and how different material and coolant configurations can impact the cost and efficacy of your shipping solution.
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![GettyImages-155372946-cold-chain-cryopreservation-logistics]( "Optimized Laboratory Kitting Is Key To Successful Clinical Trials")
Clinical trials can be completely derailed by the absence of a single component, a lack of clarity in labelling, or errors in temperature-controlled logistics.
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![GettyImages-1354171846-lab-research-development]( "Highly Potent, Perfectly Packaged")
Experts explore a project to add a contained manufacturing facility and potent packaging suite by discussing the attention to technical detail required to exceed the required high standards and regulatory controls.
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![GettyImages-1127958533 regulations]( "Strategies To Achieve Labeling Harmonization Amid A Legal Entity Change")
A strong labeling team is vital to ensure successful navigation of the legal entity change process, including developing a timeline, executing data transfers, and mitigating compliance risks.
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![Medical-research-GettyImages-1266341847]( "The Changing Landscape Of Oncology Drug Development")
Discover the guidance for navigating unique formulation and handling requirements, novel trial designs and supply chain implications, and regulatory and clinical strategies to support product approvals.
