Glossary

Integrated Summary of Safety (ISS)

An overall analysis and summary of the safety data required by the FDA for an NDA or BLA.

Resources

Take advantage of the knowledge and best practices gained from more than 20 years of research, innovation and development for the health and life sciences sectors.

Glossary

The Life Sciences glossary with terminology, acronyms, for regulatory, quality, compliance, clinical trials, and pharmacovigilance software.

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