Electronic Submissions Consulting
As Regulatory Agencies mandate the use of electronic submissions in eCTD format, development of best practices and
industry insight are imperative. Through the use of our eCTD Readiness Assessment and our extensive knowledge of
eCTD requirements and guidelines, our team provides consultation to ensure a streamlined, end-to-end submission
process.
At TruSubmit, we offer strategic guidance for businesses looking to initiate or transition current publishing operations
to electronic submissions. Our service offerings include:
- Establish a Quality System to ensure efficient processes and compliant eSubmissions or streamline existing eSubmissions processes
- Assist with lifecycle management approaches
- Enrollment and management of ESG (FDA) and eSubmission Gateway (EMA)
- Institute eCTD compliant document templates for authoring electronic documents
- Assembly of Clinical Study Reports (CSR) or other key document collections to comply with eCTD standards