RPI has been preparing electronic common technical documents for small to midsize pharmaceutical, biopharmaceutical, and medical device companies since 1995. When our trusted professionals assemble your electronic dossier, they ensure that the documentation is prepared in accordance with the electronic requirements of regulatory bodies worldwide, with the overall goal of facilitating agency review and approval of the application.
Our electronic publishing staff assures on-time submission that meets the highest quality standards, especially for clients with little or no experience in preparing electronic submissions. We accomplish this through a highly collaborative effort that results in the best possible eCTD publishing and submission service to our clients.
Services
- eCTD-ready templates for authoring submission content
- Document-level services, including document formatting and PDF generation, bookmarking and hyperlinking, case report forms, and datasets
- Preparing eCTD submission-ready clinical study reports that are ICH E3-compliant
- Conversion of paper applications to electronic form
- Submission planning and management
- eCTD builds with full validation
- Supplying a technical contact for FDA submission inquiries
- Submission lifecycle management
- Full regulatory operations service