There is no single magic formula for successful adoption of the eCTD submission format. Your organization must carefully evaluate its strengths, limitations, and priorities in order to determine the most effective solution.
GlobalSubmit’s experts have spent more than a decade acquiring the knowledge and insight needed to confidently state what constitutes a best practice. We’ve worked on regulatory submissions with more than 100 life science and biotechnology companies, and through our contractual agreement with the U.S. Food & Drug Administration, we’ve had the opportunity to analyze data from over 650,000 submissions. At the industry level, our executive management has participated in initiatives directed by the International Conference on Harmonisation (ICH), and contributed to the development of Health Level Seven (HL7) standards.
We’re committed to providing end-to-end solutions for delivering submissions to regulatory authorities, including:
- Submissions management software
- Document management software
- Regulatory information management software
- Regulatory publishing services
- Expert regulatory operations and affairs consulting
- Training and implementation
- Customer Support
- Cloud-based software deployment