Submit accurately and on time in every region
A modern submission process goes well beyond traditional publishing. Getting a dossier to a health authority accurately and on time depends on connected planning, disciplined document management, quality control built into the work, and the ability to handle many regional formats at once.
Cencora runs electronic submissions end to end, from planning and assembly through validation and lifecycle maintenance. Teams publish INDs and NDAs, biologics license applications (BLAs), marketing authorization applications (MAAs), and abbreviated new drug applications (ANDAs), in eCTD for ICH regions and in the formats non-ICH markets require.
Cencora runs electronic submissions end to end, from planning and assembly through validation and lifecycle maintenance. Teams publish INDs and NDAs, biologics license applications (BLAs), marketing authorization applications (MAAs), and abbreviated new drug applications (ANDAs), in eCTD for ICH regions and in the formats non-ICH markets require.
Remove the rework that pushes filing dates
Publishing problems rarely surface early. They appear at validation, when a formatting decision made months earlier turns into a failed submission and a missed window. Cencora catches them upstream.
Diverging regional formats
Each region sets its own electronic format, and standards such as eCTD 4.0 and IDMP keep moving, so currency is constant work.
Volume against deadlines
High submission volumes meet fixed regulatory deadlines, and there is rarely enough slack in the schedule to absorb a quality escape.
Inconsistent source documents
Formatting, templates, and document quality vary by author, and every inconsistency becomes a publishing or validation problem further down.
End-to-end submission support across ICH and non-ICH markets
You get submission planning and multi-region coordination, document formatting and quality control, electronic publishing and validation, and the regulatory information systems that hold it all together.
Filings run in eCTD for ICH regions and in the formats non-ICH markets require, with lifecycle maintenance continuing after approval.
Filings run in eCTD for ICH regions and in the formats non-ICH markets require, with lifecycle maintenance continuing after approval.
What we offer
Submission planning and management
End-to-end planning, timeline development, and multi-region coordination handled by regulatory project managers who own the schedule.
eCTD publishing and validation
Electronic publishing and submission for IND, NDA, BLA, MAA, ANDA, and drug master files across ICH and non-ICH regions.
Document processing and control
Formatting, templating, PDF rendering, bookmarking, hyperlinking, and document-level quality checks before anything reaches the publishing stage.
Regulatory information management
Selection, implementation, validation, and day-to-day operation of regulatory information systems, including data migration and ongoing maintenance.
Standards and transition support
Support for current and emerging submission standards, including eCTD 4.0, IDMP, structured product labeling, and regional formats.
Publishing technology
Submission-ready assembly, validation, and publishing supported by Lorenz docuBridge and other industry-standard tooling, with built-in quality checks.
Why choose Cencora for publishing and electronic submission services
Errors caught upstream
Quality checks run at every stage, so formatting issues are fixed long before they can fail validation.
Every regional format
One team handles eCTD for ICH regions and the formats non-ICH markets require, so every filing runs from one plan.
Continuity beyond approval
Lifecycle maintenance continues after approval, keeping your dossier current and compliant as standards and regional requirements change.
Expert insight
Another learning was that besides the actual eCTD compilation and submission process, applicants would need to look into their internal processes of exchanging complete eCTD sequences with external partners, as these processes may also be affected by the new format.
— Karl-Heinz Loebel
Key takeaways from the eCTD 4.0 EU technical pilot
Related solutions
Integrated submission readiness assessment
Navigate NDA, BLA, and MAA submissions with cross-functional regulatory support and an independent readiness assessment before filing.
Regulatory lifecycle management and maintenance activities
Keep approved products compliant and available after launch with variations, renewals, labeling, and post-approval maintenance in the markets you serve.
PharmaLex is now Cencora
Publishing and electronic submission services is part of our Commercialization support capability. Same team, same expertise, now with greater reach.
Need more information about publishing and electronic submission services?
Our team of experts is here to assist you. Whether you have questions or need more detailed information, don’t hesitate to get in touch. We’re dedicated to providing the support you need.