Publishing & eCTD Services

Pharmaceutical companies face a host of operational challenges in managing global regulatory affairs submissions. These include meeting timelines and complexity in the development and dynamic regulatory and patent environment throughout the year, variations in requirements from region to region.

IPHARMED provides complete end to end services for building the dossier writing to publishing services.

Let us assist you with :

• Conversion of Paper based submission or legacy documents to NeeS or eCTD submissions as per region or country specific guidelines.
• PDF formatting and hyperlinking issues, floating sections, and error corrections.
• Extension of the in-house publishing team and management of the submission tools with Business Process as a Service (BPaaS) model
• End to end services for Publishing, Submission and Archival of Dossiers for multiple regions
• Management and Submission of IND Safety & Adverse Event Reports
• Document Formatting and Publishing – Word Style Guides and PDF Navigation