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New Standard for Vaccine Storage Units

Electrical Safety and Performance Considerations 23 March 2021 One of the key tools in combatting [...]

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Borderline Cosmetics in the EU

Understanding a product’s classification for regulatory compliance The distinction between product classes can be unclear [...]

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Biomarker Discovery, Technical Qualification and Validation

Using LBA, LC-MS and HRAMS Assay Formats Biomarker validation is a valuable tool in drug [...]

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Bioanalysis and Immunogenicity Series – Volume 1

FDA Expectations Regarding Immunogenicity Testing Starting with insulin development in the 1920s, therapeutic proteins have [...]

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The Bridge to China

Medical Device Approvals with the National Medical Products Administration (NMPA) In China, medical device manufacturers [...]

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Driving compliance and transparency in pharma supply chains

Why the alignment of audit scope with the correct industry standard is important Pharmaceutical supply [...]

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