Regulatory Electronic Submission Publishing Services

Regulatory Electronic Submission Publishing Services for the Pharmaceutical and Healthcare Industry.

Intertek’s regulatory operations experts offer complete electronic submission publishing services including:

• Electronic submission formatting, optimization, construction, assembly, and review 
• Review of documents for compliance to electronic submission requirements for regulatory agencies 
• Document conversion, bookmarking, hyperlinking, enhancement, optimization, and quality control 
• Electronic Common Technical Document (eCTD) submission and lifecycle management services for various submission types (e.g., NDA/BLA/IND, NDS/VNDS/SNDS/ANDS/CTA, DIN submissions, DMFs, Annual Reports, etc.)
• Conversion of paper dossiers (e.g., DMFs) to eCTD format
• Medical device electronic submissions

Intertek is committed to quality and utilize a multi-faceted quality control review process for completeness and compliance to electronic submission standards for every submission. Intertek uses an industry standard electronic submission publishing software and validation platform.

The following services are also available:

• Strategic, process, and technical advice
• Validation with technical troubleshooting and resolution
• Use of Intertek’s Electronic Submissions Gateway (ESG) account
• On-site setup of ESG systems (WebTrader)