Transitioning to eCTD
Converting from paper to electronic common technical document (eCTD) format can be difficult, but an experienced partner, such as Synchrogenix can help fill the knowledge gaps and share industry best practices, while also helping you achieve submission success simply, quickly, and cost-effectively.
Electronic common technical document (eCTD) is increasingly becoming the standard format for submitting many applications to agencies around the globe. It is already the required format for submitting applications, amendments, supplements, and reports to the U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).
Per U.S. FDA eCTD Guidance, the following must be submitted using eCTD format:
- New Drug Applications (NDAs)
- Abbreviated NDAs (ANDAs)
- Biologics License Applications (BLAs)
- Commercial Investigational New Drug Applications (INDs)
- Master Files
Are you prepared to implement eCTD?
- Does your company have eCTD publishing software?
- Does your company have appropriately trained staff?
- Has your company made the broader, organizational changes necessary to create eCTD submission-ready documents?
Synchrogenix’s team of publishers brings over ten years’ experience in helping to convert clients from paper to electronic format. Full or partial submission outsourcing is a popular option for smaller pharmaceutical and biotechnology companies implementing eCTD.
Watch our video to see how our team of publishers brings over ten years of experience to help convert companies from paper to electronic format.
Implementing eCTD Through Outsourcing
Transitioning to eCTD inevitably requires change. To plan the transition, you must determine your short and long-term objectives, how document control will be handled, and what process changes are needed.
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- Recommendations for short vs. long-term submission goals
- Document management
- Three main business process changes to implement