The electronic Common Technical Document (eCTD) is an electronic format used for regulatory submissions to Health Authorities globally. eCTD submissions streamline the creation and review of regulatory information, allowing for a more efficient review process and therefore accelerating market approval.
Preparing your submission for Health Authority review can be overwhelming. Partnering with an experienced submission publishing company can streamline the process. Outsourcing eCTD publishing to a qualified vendor offers several advantages compared to handling the publishing in-house.
Experience/Expertise: Qualified vendors employ people with knowledge of the current eCTD requirements and those with extensive experience in efficiently publishing compliant submissions.
Cost: Outsourcing eliminates the high costs of implementing, validating and maintaining an eCTD publishing tool. Avoiding the need to hire specialized and experienced publishers results in additional cost savings.
Time: A great amount of time is required to implement and validate an eCTD publishing tool and outsourcing means that time is saved. Moreover, an experienced publishing firm can accelerate the submission process, helping to meet deadlines without delay and expedite regulatory review.
Quality/Compliance: Entrusting the eCTD publishing to an experienced vendor with knowledge of the regulatory and technical requirements can minimize the risk of errors and rejections by the Health Authorities. Qualified vendors have established processes designed to enhance submission quality and ensure compliance.
Flexibility: Publishing needs evolve over time. Outsourcing allows services to be scaled up or down based on the needs of the company and volume of submissions without the need to adjust internal personnel.
Overall, outsourcing submission publishing enables companies to navigate complex regulatory environments more efficiently, letting them focus on their core business activities while ensuring high-quality and compliant submissions.
How can Regxia Help?
Regxia has been publishing compliant eCTD submissions to Health Canada and the FDA since 2008 using a validated eCTD publishing tool. Regxia has an experienced team that is familiar with both the regulatory and technical requirements. The team works efficiently to meet deadlines and prides itself on its quality and attention to detail. Our internal procedures ensure that your submission is consistently compiled and published accurately.
Our services
Submission planning and management
Preparation of “e-ready” documents (word-processing, formatting, etc.)
eCTD submission publishing and lifecycle management
Transfer and ongoing support of existing eCTD submissions from other vendors
Adaptation of existing global eCTD submissions to meet Health Canada and FDA requirements
If you’re thinking about outsourcing submission publishing or switching vendors, reach out to us to discover how we can help.
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