We offer a standard list of services and custom designed solutions for your project, specializing in eCTD submissions via the Electronic Submissions Gateway (ESG).
- Introduction and orientation to the eCTD and document granularity
- Generation of easy-to-use templates in MS Word to minimize revisions (includes pre-formatted tables for entry of tabulated summary data)
- Style guides customized to your project to maintain continuity in font styles, use of product name, abbreviations, italics, units of measure and symbols
- Roadmap to the required FDA guidances to direct authors’ input
- Assistance with placement of documents within the eCTD structure
- Cleanup of any files provided in MS Word prior to rendering to PDF (includes basic formatting, table of contents generation, if required, insertion/validation of table/figure captions and cross-reference hyperlinking, and intra-document hyperlinks as required
- Conversion of source documents to PDF and/or remediation of client-provided PDF files to FDA-compliant PDF files
- Validation of client-provided PDF files and insertion and/or validation of all intra- and inter-document hyperlinks
- QC review/training and/or remediation of client-formatted Word and PDF files
- Lorenz docuBridge software training
- Compilation of files into the eCTD XML Backbone using Lorenz docuBridge and docuBridge ONE
- QC and validation of the final eCTD sequence to ensure technical compliance
- Submission of eCTD via the Electronic Submissions Gateway (ESG)
- Preparation of final working files for client electronic archiving
- Conversion of ex-US applications for submission to the FDA
- Staff training to generate FDA-compliant PDF files
- Software training and assistance for DocuBridge ONE