In an environment of continually evolving regulations, we provide electronic publishing and lifecycle
management services for the Biotechnology, Pharmaceutical, and Medical Device industries worldwide. At
TruSubmit, our proven Quality Systems and professional insight allow us to tailor our services on a per
client basis; providing your business with innovative solutions to ensure Agency compliance.
We offer a wide array of services for businesses looking to outsource electronic publishing operations.
Our service offerings include:
- eCTD publishing, compilation and validation
- Conversion of legacy (paper or non-eCTD) submissions to eCTD format
- Processing alternate submission formats including Non-eCTD electronic Submissions (NeeS), for Sponsors and Agencies that have not transitioned to eCTD
- Structured Product Labeling (SPL), including Drug Establishment Registration, Drug Listing and Labeler Code Request
- Transmission of electronic submissions to the FDA via the Electronic Submissions Gateway (ESG) and to EMA via the eSubmissions Gateway