eCTD Publishing
Compile, validate and deliver eCTD sequences that are ready for the agency the first time.
- Sequence build and lifecycle management
- Hyperlinking and bookmarking
- Pre-submission quality checks
Regulatory operations for life sciences
Submission-ready eCTDs, built with meticulous care.
eCTD publishing, regulatory document management and document formatting from a specialist with more than 25 years in Regulatory Operations.
Call 302-293-2742 · Monday to Friday, 7am to 6pm ET
25+ years
in Regulatory Operations
Many therapeutic areas
across a diverse range of companies
One specialist
you work with Ian directly, start to finish
Services
Everything between a finished document and an accepted submission.
Bring in a specialist for one sequence or for the whole lifecycle. The work is accurate, efficient and compliant, and tailored to how your team already operates.
Regulatory Document Management
Keep submission content organized, controlled and easy to find when the next sequence comes around.
- Document control and version tracking
- Submission archive organization
- Process support for your team
Document Formatting
Turn author drafts into clean, consistent documents that meet agency and eCTD standards.
- Template application and styling
- Submission-ready PDF output
- Tables, figures and cross-references
How we work together
A simple process, with no surprises.
01
Talk it through
A short call about your submission, timeline and the help you need.
02
Agree the scope
A clear plan with deliverables and dates before any work starts.
03
Build and check
Publishing and formatting done with meticulous attention to detail.
04
Deliver
Submission-ready output, on time, with someone to call if questions come up.
Software · eCTDViewer
Open, browse and check eCTD submissions in your browser.
Built by a publisher for publishers. Your files stay on your computer and are never uploaded.
- Navigate the full CTD tree, sequence by sequence
- Follow every document’s lifecycle across sequences
- Check hyperlinks and bookmarks in one click
- Read regional administrative information at a glance
About Ian
“Meticulous detail is how you get exceptional results.”
Ian Oldham has spent more than 25 years in Regulatory Operations, working with a diverse range of companies across many therapeutic areas. That experience shapes a detail-oriented approach, with solutions tailored to each client rather than a one-size-fits-all process.
Have a submission coming up?
Tell me what you are working on. I will reply within one business day with how I can help.