Without specialized tools and processes, assessing large volumes of data for compliance can be time-consuming.
Streamlined Handling:
Effortlessly navigate through submission structures in various view modes.
Enhanced Reporting:
Simplify the creation of assessment reports by easily exporting annotations.
Scalable Validation:
Suitable for numerous internal and external users, even in environments with limited IT resources.
Comprehensive Life Cycle Management:
Enjoy quick access to submissions throughout the entire lifecycle of a medicinal product.
Submission Management software tools are designed to meet the needs of both the pharmaceutical and crop industry. They cover all global standards like eCTD or NeeS. We provide safe and compliant submission and lifecycle management software, which is essential for your business success in the fast-changing and highly regulated environment of these industries. All hubs provide you the greatest flexibility in designing your IT infrastructure on-premise or cloud-based.
More than 35 regulatory authorities work with us to ensure eCTD and NEES compliance. Ensure compliance with regulatory requirements worldwide. Reduce errors and increase productivity through advanced automation.
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