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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

EMA HTA Parallel Scientific Advice

When developing a medicinal product, two milestones are of importance for making its path to…

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M

Monitoring Plan

Describes the monitoring methods, responsibilities, and requirements for the trial. It includes a brief description…

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