IDDS-CMC (Chemistry, Manufacturing & Controls) Workbench
The CMC Workbench™ consists of critical non-clinical functions associated with drug design such as formulation development, analytical development, stability, scale up, and manufacturing. CMC Workbench focuses on orchestrating these processes. The Workbench is designed to handle global drug development programs in alignment with standardized, regulated processes.
CMC Workbench saves a significant amount of time in product development. This enables faster drug selection, reduced study costs and improved success rates.
The CMC Workbench is specifically designed to handle drug development projects in a manner that is compliant with FDA (Food and Drug Administration) and ICH (International Conference on Harmonization) guidelines.
Key features include:
- Enables integration of legacy systems with knowledge bases and decision-support systems over a company's Intranet.
- Allows real-time collaboration with project team members situated across the globe or on the move.
- Provides access to regulatory guidance (based upon FDA recommendations as well as the International Conference on Harmonization's Common Technical Document - ICH-CTD) in discrete functional silos of the development process from preclinical to clinical supplies, to final regulatory submissions.
- Includes Process Mapping Toolkit that enables mapping of a full range of process triggers and workflows
- Empowers scientists (users) to configure the system to their personal needs and processes
To Learn More
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Call: +1 (650) 350-1900