Regulatory Electronic Submission Publishing Services

Electronic submissions are required for many regulatory submission types for regulatory authorities globally. Leveraging industry-leading eCTD publishing tools and supporting multiple regions (e.g., United States, Canada, Europe), our team of qualified, experienced professionals consistently produce compliant, “first-time-right” submissions ranging from small to large and complex dossiers or applications. Our experts are committed to quality - we implement a multi-faceted quality control review process for completeness and compliance to electronic submission standards for every submission.

How can Intertek help?

Intertek’s Broad Capabilities:

Supported by a skilled and accomplished Regulatory Affairs team, our Electronic Submission Publishing group offers full management and publishing of the following submissions in eCTD format:

• US FDA: NDA, BLA, IND, Amendments, Veterinary Submissions, DMF, Annual Report, AdPromo, all supporting submissions, and more.
• Health Canada: NDS, SNDS, ANDS, NC, CTA, DIN, DMF, all supporting submissions, and more.
• EMA: MAA, Variations, ASMF, CTA, and more.
• Conversion of paper dossiers (e.g., DMF) to eCTD format or other electronic formats.

Specific Services Available:

• Complete end-to-end submission publishing and lifecycle management  .
• Strategic, process, and technical advice.
• Document-level publishing (conversion, enhancement, optimization, OCR, bookmarking, hyperlinking, document properties, quality review).
• Submission-level publishing (eCTD compilation, naming best practices, inter-document hyperlinking, quality review, validation).
• Publishing of fully compliant ICH E3 Clinical Study Reports.
• Gateway submittal services  including US FDA Electronic Submissions Gateway, Health Canada Common Electronic Submissions Gateway, EMA eSubmission Gateway, HMA Common European Submission Portal.
• Quality control review of client-generated submissions for ICH and regional compliance.
• Validation troubleshooting.
• Dataset preparation for eCTD submission (SDTM, ADaM, SEND), including creation of Simplified TS.xpt files when required.
• SPL and XML PM labelling support.
• Health Canada Regulatory Enrolment Process (REP) support.