Introduction
In today’s highly regulated pharmaceutical and healthcare landscape, regulatory publishing and submission play a critical role in ensuring that life sciences companies bring their products to global markets successfully. Whether it’s a new drug application, biologic, medical device, or generic, companies must adhere to strict submission requirements set by regulatory authorities like the FDA, EMA, PMDA, Health Canada, TGA, CDSCO, and others.
Regulatory publishing and submission involves the preparation, formatting, validation, and electronic submission of documents in compliance with regional guidelines, primarily in eCTD (Electronic Common Technical Document) format. With ever-changing global regulations, ensuring compliance, accuracy, and timely submissions can be challenging without expert support.
That’s where we come in. Our Global eCTD Regulatory Publishing & Submission Services are designed to support pharmaceutical, biotech, and medical device companies throughout the entire product lifecycle—from pre-approval to post-marketing maintenance.
What Is Regulatory Publishing & Submission?
Regulatory publishing and submission is the process of preparing and delivering regulatory dossiers to health authorities in required formats such as eCTD (Electronic Common Technical Document) or NeeS (Non-eCTD electronic Submissions). It includes:
- Compiling clinical, non-clinical, and CMC data
- Structuring documents according to regional requirements
- Formatting, hyperlinking, bookmarking, and validation
- Submitting dossiers electronically to global regulatory agencies
Failure to comply with these requirements can lead to delays, rejections, or non-approval of marketing applications, making professional regulatory submission services critical for life sciences companies. To further strengthen compliance and product safety, our expert Toxicology Risk Assessment services ensure that potential risks are identified and mitigated early in the development process.
Why It’s Critical for Pharma, Biotech, and Medical Devices
- Accelerates time-to-market: A compliant, error-free submission ensures faster regulatory review and approval.
- Ensures global compliance: Different agencies (FDA, EMA, CDSCO, PMDA, etc.) have unique requirements—publishing expertise ensures alignment.
- Reduces rejection risk: Proper formatting, validation, and quality checks minimize chances of rejection.
- Supports lifecycle management: Submissions don’t end at approval; ongoing updates, renewals, and variations require continuous publishing support.
Our Services
eCTD Publishing & Validation
We prepare, publish, and validate regulatory dossiers in eCTD/NeeS formats, ensuring they meet all regional authority standards. Our validation tools detect errors before submission, reducing risks of rejection.
Global Regulatory Submission Services
End-to-end submission support across all major global markets including FDA, EMA, MHRA, PMDA, Health Canada, TGA, CDSCO, GCC, and EAEU.
Document Formatting & Standardization
Professional formatting of regulatory documents (Word, PDF) including hyperlinking, bookmarking, pagination, and template compliance as per ICH and agency-specific standards.
Submission Readiness & Compliance Check
Pre-submission review to ensure dossiers are structured, formatted, and validated according to regulatory requirements.
Lifecycle Management of Submissions
We manage post-approval submissions such as variations, renewals, amendments, safety updates, and annual reports.
Regulatory Project Management
Dedicated project managers ensure seamless coordination, clear timelines, and transparent communication throughout the publishing and submission process.
As part of our regulatory expertise, we also provide insights on Extractables & Leachables Risk Assessment in packaging, helping companies ensure product safety and compliance with evolving industry standards.
Global Compliance Coverage
We provide regulatory submission support worldwide, covering:
- US FDA (Food and Drug Administration)
- EMA (European Medicines Agency)
- MHRA (UK Medicines and Healthcare products Regulatory Agency)
- PMDA (Pharmaceuticals and Medical Devices Agency, Japan)
- Health Canada
- TGA (Therapeutic Goods Administration, Australia)
- CDSCO (Central Drugs Standard Control Organization, India)
- GCC (Gulf Cooperation Council)
- EAEU (Eurasian Economic Union)
Industries We Serve
Our expertise extends across multiple sectors of life sciences:
- Pharmaceuticals (NDA, ANDA, IND submissions)
- Biotechnology (Biologics, vaccines, advanced therapies)
- Medical Devices (Regulatory submissions for global device approvals)
- Generics & Biosimilars
- CROs (Contract Research Organizations supporting global submissions)
Regulatory Submission Process (Step-by-Step)
- Document Intake & Formatting – Collect and format documents according to agency templates.
- Publishing in eCTD/NeeS – Convert, structure, and organize content for electronic submission.
- Validation & QC – Run technical validation and quality checks to eliminate errors.
- Submission to Authorities – Deliver submission packages securely to global health agencies.
- Lifecycle Management & Updates – Handle variations, renewals, and ongoing post-approval submissions.
Why Choose Us?
- Proven global expertise across multiple markets
- Faster turnaround times with on-time delivery
- High accuracy & compliance with regulatory guidelines
- Dedicated project managers for end-to-end support
- Secure handling of confidential data with strict compliance to industry standards
FAQs About Global eCTD Regulatory Publishing & Submissions
1. What is eCTD in regulatory submissions?
The Electronic Common Technical Document (eCTD) is the global standard format for submitting regulatory applications to health authorities. It streamlines submission review and lifecycle management.
2. Which agencies accept eCTD submissions?
Agencies such as the FDA, EMA, PMDA, Health Canada, TGA, CDSCO, and MHRA require or strongly encourage eCTD submissions.
3. What happens if a submission fails validation?
If a submission fails validation, it may be rejected, delaying the review process. Professional publishing services ensure validation errors are fixed before submission.
4. Do medical devices also require eCTD submissions?
Yes. While historically used for pharmaceuticals, many regions now accept or mandate eCTD submissions for medical devices and combination products.
5. What’s the difference between eCTD and NeeS?
NeeS (Non-eCTD electronic Submission) is an older electronic format. eCTD has now become the global standard for better lifecycle management and efficiency.
6. Can you handle post-approval regulatory submissions?
Absolutely. We manage lifecycle submissions such as variations, renewals, annual reports, and safety updates.
7. How do you ensure global compliance for different regions?
Our experts follow ICH guidelines while tailoring submissions to specific regional requirements, ensuring compliance across multiple health authorities.
8. Why outsource regulatory publishing and submission services?
Outsourcing reduces operational burden, ensures expert handling, minimizes errors, and accelerates time-to-market for new products.