GlobalSubmit recommends a holistic approach to eCTD readiness. We have extensive domain experience with the full lifecycle management of the eCTD. During our years of work with the U.S. FDA and global Life Sciences companies, we’ve collected and compiled a set of best practices that address many of the key pitfalls and implementation challenges associated with eCTD adoption. We are active participants in the ICH and HL7, and because of this, we’re considered to be the go-to thought leaders in the industry. In fact, recently we were asked to provide significant guidance in the development of the Regulated Product Submission (RPS) standard and we’ll be on the decision making board as that standard develops. eCTD readiness then, is not a want-to-have, it’s a need-to-have. We hope that the Best Practices offered here will help you get to get right where you need to be. Note that while these best practices will provide key insight into today’s relevant strategies, they’re not all inclusive.
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