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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

E

European Network for Health Technology Assessment (EUnetHTA)

The European network for Health Technology Assessment is a network of government-appointed organizations from European…

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I

Investigational Device Exemption (IDE)

Approval of an Investigational Device Exemption (IDE) submission must occur by the FDA before a…

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