Moving towards the eCTD requires a clear understanding of the processes and best practices to ensure success.  There are many valuable "lessons learned" that could help smooth your path towards eCTD readiness and adoption. 

GlobalSubmit has extensive domain experience with the full life cycle management of the eCTD.  Through our work with the U.S. FDA and global life sciences companies, we have compiled a set of best practices that address many of the key pitfalls and implementation challenges associated with eCTD adoption.  We also are active participants in the ICH HL7 group and provided significant guidance and thought leadership in the development of the Regulated Product Submission (RPS) standard.   Best practices in this area reflect our experience with this initiative. 

Successful adoption of the eCTD involves the strategic integration of the right people, processes, and technology.  Many organizations focus only on technology solutions while ignoring relevant staffing and process challenges.  GlobalSubmit recommends a holistic approach to eCTD readiness.  Our best practice topics are categorized based on some of the most challenging aspects of eCTD adoption.  While not all inclusive, these best practices will provide key insight into today's relevant strategies.