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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

S

Sensitive Data

Data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, or trade union…

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V

Voluntary Harmonization Procedure (VHP)

When a sponsor wishes to carry out a clinical trial in two or more EU…

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