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Glossary

Assay

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(For Small Molecule and Synthetic Low Molecular Weight Peptide Drug Substances) A specific, stability-indicating procedure that determines the content of the drug substance.

 

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Solutions for the UK

The UK market is independent of the European Union and has its…
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Regulatory Strategy & Submissions

Design and implementation of global patient-centric regulatory strategies to ensure expedited product…

Other glossary definitions

L

Listedness

An Adverse Event is considered “listed” if it is described in the product’s Company Core…

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I

Incident for Medical Device (MEDDEV definition)

Any malfunction or deterioration in the characteristics and/or performance of a device, including use-error due…

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