Glossary

eCTD Backbone

The Submission XML Table of Contents file which provides an interface for industry-to-agency transfer of regulatory information that takes into consideration the facilitation of the creation, review, lifecycle management and archival of the submission.

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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