eCTD Publishing Services
Compliant. Streamlined. Submission ready.
What to Know About eCTD Publishing
The electronic Common Technical Document (eCTD) is the global standard for submitting regulatory information to health authorities. Used for applications such as INDs, NDAs, BLAs, ANDAs, and 510(k)s, the eCTD format allows for structured, consistent, and efficient submissions that facilitate regulatory review. It is required by the FDA and adopted by many other global agencies.
An effective eCTD publishing process ensures that your submission is:
- Structured according to ICH specifications and regional guidance
- Technically validated to prevent rejections or delays
- Clear, consistent, and easy to navigate by regulators
- Ready for submission through electronic gateways like ESG or CESP
Poorly formatted or non-compliant submissions can lead to unnecessary delays, additional costs, or even refusal to file. This makes expert eCTD publishing an essential component of any regulatory strategy.
Accelerate Your Regulatory Submissions with Expert eCTD Publishing
Whether you are preparing an IND, NDA, BLA, ANDA, or510(k), your electronic Common Technical Document (eCTD) must meet strict formatting and technical requirements. Our experienced publishing team ensures your documents are fully compliant with FDA and international regulatory authority specifications and ready for timely submission.
Why eCTD Compliance Matters
Submitting in eCTD format is not merely a technical formality. It is a regulatory imperative. Formatting errors, broken hyperlinks, or validation failures can result in significant delays or even a refusal to file. Our experienced eCTD publishers deliver:
- Precise formatting and hyperlinking
- Accurate metadata and folder structure
- Validation aligned with the latest agency specifications (FDA, EMA, Health Canada, etc.)
- Rapid turnaround for urgent or last-minute submissions
Our eCTD Publishing Services Include:
Comprehensive publishing setup and consultation
Full lifecycle management of regulatory dossiers
Pre-submission validation and quality control
Hyperlinking, bookmarking, and PDF optimization
eCTD publishing for INDs, NDAs, BLAs, ANDAs, 510(k)s, PMAs, and amendments
Regulatory gateway submission (ESG, CESP, etc.)
Embedded Support for Seamless Integration
We provide more than just document delivery. GLOBAL functions as a true extension of your regulatory operations. Through our FTE model, publishers are integrated into your systems and workflows, and supported by GLOBAL’s internal network of experts. Clients benefit from:
- Consistent and transparent communication
- Streamlined internal review and approval processes
- Fewer revisions and shorter submission timelines
- Harmonized formatting and publishing across all deliverables
Tips for Successful eCTD Submissions
Why Partner with GLOBAL for eCTD Publishing?
For over a decade, GLOBAL has supported sponsors in accelerating access to market through high-quality regulatory writing and submission services. Our publishing professionals bring a blend of technical accuracy and regulatory insight to ensure your documentation is accurate, compliant, and submission-ready—regardless of complexity.
What sets us apart:
Proven experience with FDA and EMA submissions
Proficiency with industry-standard publishing platforms
Real-time issue resolution and expert troubleshooting
Scalable services for both individual submissions and entire portfolios
Submit with Confidence
Avoid unnecessary delays and ensure your submissions meet every technical requirement. Let GLOBAL deliver reliable, professional eCTD publishing support tailored to your needs.
Contact our publishing team today.
Whether you require full-service publishing or supplemental capacity during high-volume periods, GLOBAL is prepared to support your regulatory goals.
