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Templates Creation
Simplify document creation, collaboration, and approval processes.
Ensure version control and traceability for all regulatory documents.
Facilitate seamless integration with existing enterprise systems.
eCTD Publishing
Accelerate the submission process with efficient electronic Common Technical Document (eCTD) publishing.
Ensure compliance with global regulatory standards for electronic submissions.
Streamline the compilation, validation, and lifecycle management of eCTD dossiers.
ICH Validations
Validate against International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) validation standards.
Ensure data integrity and accuracy throughout the regulatory lifecycle.
Expedite the validation process to meet regulatory timelines effectively.