A typical regulatory submission via paper includes thousands of pieces of data that need to be compiled, managed and revised several times for accuracy and integrity. As a result, it is not uncommon for data errors or delays to prolong the submission of an application. In 2009, FDA announced they were preparing legislation to universalize the eCTD and require electronic submissions for future drug applications.
At RPI, the submission process can be streamlined using the electronic Common Technical Document (eCTD) – an interface which restructures submissions into a more manageable and efficient format. Our Regulatory Operations team has the ability to adapt to any Client's needs by making eCTD templates readily available for authoring, structuring and generating PDFs for easy navigation, and supporting the application throughout the submission lifecycle. The primary focus of RPI's eCTD is to expedite the data exchange between the Client and the Agency.
RPI distinguishes itself from other companies offering electronic publishing services with over 25 years of experience in regulatory affairs. RPI's publishers are highly skilled, with university degrees and 10 or more years of publishing and document management experience. Our goal is not only to guide Clients through the eCTD process, but to involve them in every decision leading to Agency approval.
Electronic Submission Services (ESS)
- eCTD ready templates for authoring submission content
- Document formatting and PDF generation
- Bookmarking and hyperlinking documents, CRFs, datasets
- Prepare eCTD submission ready Clinical Study Reports
(organize Appendix 16 documents and hyperlink to report body)
- eCTD compiled, validated and ready for client review
- Submission planning and lifecycle management
- Organize PDF files containing metadata and lifecycle instructions to ensure the data is properly transferred to Agency reviewers and can be easily navigated
- Well organized submissions facilitate Agency review and approval
- RPI's expertise in Regulatory Affairs and Regulatory Operations provides a highly collaborative effort that results in the best possible service to our Clients.