Health Authorities around the world now require clinical trial documentation, regulatory applications, and marketing applications to be submitted electronically, improving the efficiency of delivery, formatting, and review of the files, documentation, and applications submitted.
Sponsors often underestimate the time and effort required to preflight, publish, and submit materials to regulatory authorities and agencies, whether through the FDA’s Electronic Submissions Gateway (ESG) or an equivalent global portal. Our experienced team of regulatory publishers average 10–14 years of industry publishing experience, helping anticipate challenges and keep the process on track.
Overcoming Regulatory Publishing Challenges
We've taken over publishing mid-registration before. One IND transferred to us from another vendor needed nearly all of its content substantively reviewed and modified before it was submission-ready, we brought it to a successful FDA submission and approval.
That outcome came from integration, not just publishing expertise on its own. Our regulatory publishing experts will work with you to establish realistic timelines and best practices for publishing single documents or full marketing applications. Using the right publishing team that is fully integrated with your regulatory and writing teams can help you find efficiencies to reduce timelines.
All submissions are electronically published using an industry-leading technology platform with templates our publishers have customized to meet the real-world needs of every submission. Whether you're early in development or reconsidering your current publishing partner, that's the model we bring.
How It Works
A Proven Regulatory Publishing Process
01
Plan.
We establish realistic timelines and best practices before publishing begins, whether for a single document or a full marketing application.
02
Pre-publish.
Document-level processing. Includes document formatting in our templates as mentioned, converting to PDF, and ensuring the appropriate bookmarks and internal hyperlinks are present to meet eCTD guidance.
03
Document QC.
Perform document-level QC prior to eCTD build. Performed by a secondary publisher.
04
eCTD Build.
Place documents into respective sections within the eCTD structure. Create hyperlinks between documents, ensure completeness of submission.
05
Submission QC.
A secondary publisher checks external hyperlinks, document file tags, and general completeness of submission.
06
Review.
Client review/approval of submission. We can also engage our Regulatory Strategists for this part.
07
Submit.
Push the actual transmission through the appropriate health authority gateway or portals.
08
Archive.
Final documents and the completed submission are archived and transferred.
Expert Regulatory Filings Throughout the Entire Development Journey
Our team of regulatory publishers offers end-to-end publishing support for your program from a regulatory, CMC, and clinical perspective. They write and submit the following types of dossiers/documents, including:
Preclinical/ IND Stage
Full INDs
Investigator Brochures (IBs)/Documents
Protocols
Briefing Books/Agency Meeting Requests
During Clinical Trials
Protocols/Amendments
Safety Updates
SAEs
Clinical Study Reports (CSRs)
Clinical Trial Datasets/DMFs
Briefing Books/Agency Meeting Requests
Expedited Pathway/designation applications
Registration/Post-Marketing
Marketing Applications (NDAs, BLAs, MAAs, etc)
Annual Reports/DSURs
Periodic/Yearly Safety updates
Advertising Promotions
Risk Management Plans
VERISTAT’S PROVEN IMPACT
In the past year...
These numbers reflect programs we've supported from strategy through submission.
94
Sponsors supported with publishing of INDs, clinical trial documents and marketing applications
16
INDs published
04
Marketing Applications published
NEXT STEPS
What's Next in the Drug Development Process
Regulatory Consulting.
Apply our knowledge and insights to plan and implement regulatory strategies for successful interactions with Regulatory Agencies.
We write clinical trial and regulatory documents tailored to meet the specific requirements of the product, therapeutic indication, and regulatory agency.
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Let's Talk About Your Next Submission (Heading).
From first IND to global marketing application, our publishers deliver submission-ready dossiers on time. Tell us about your program, and an expert will follow up.
Document formatting (pre-publishing) prepares individual files, converting them to PDF and adding the bookmarks and hyperlinks required for eCTD, while eCTD publishing places those documents into the correct eCTD structure and builds the hyperlinks between them to create a complete, submission-ready dossier.
Yes. Veristat has taken over publishing mid-registration before, including an IND transferred from another vendor that required substantive review and modification, which Veristat carried through to a successful FDA submission and approval.
Submissions go through two rounds of quality control performed by a secondary publisher, one at the document level before the eCTD build, and one after, checking external hyperlinks, file tags, and overall completeness of the submission.
