Global eCTD Publishing and Submission Services

Global eCTD Publishing and Submission Services are essential for life sciences organizations striving for timely, accurate, and globally compliant Regulatory submissions. Freyr’s dedicated team, specializing in Global eCTD Publishing and Submissions, leverages the proprietary eCTD publishing tool, Freya.Submit, to ensure adherence to region-specific Health Authority (HA) requirements and ICH guidelines. From data compilation to lifecycle management, our team ensures full compliance with the eCTD format, including proper structuring, metadata tagging, and document-level publishing—enabling smooth eCTD Submissions across global markets.

Freyr’s services include high-quality dossier planning, QC, dispatch, archiving, and tracking. With ad hoc, last-minute, and long-term engagement models, we support clients with technical project management, global reach, and agile eCTD publishing workflows that ensure submission accuracy and speed.

Global eCTD Publishing and Submission Services - Overview

The electronic common technical document (eCTD) is the global standard for structured Regulatory submissions, enabling life sciences companies to submit applications, amendments, and supplements in an accepted eCTD format. Global eCTD Publishing and Submissions simplify the compilation and review of data using hyperlinks, bookmarks, and metadata for quicker agency assessments.

Freyr’s experience in handling eCTD Submissions for agencies like the USFDA, EMA, and other global HAs enables life sciences companies to stay compliant across jurisdictions. Our Global eCTD Publishing and Submission services include support for both eCTD and Non-eCTD Electronic Submissions (NeeS), ensuring flexible solutions for every type of regulatory pathway. Powered by eCTD publishing tools like Freya.Submit, we guarantee consistency, accuracy, and speed in every submission.

We partner with leading pharmaceutical companies in Japan, the US, and EU, delivering successful submissions, training, and technical consultation. Our robust services and software are fully prepared to support seamless eCTD 4.0 adoption across all three regions for our clients

Freyr has executed over 200,000 + successful submissions globally, with 400+ publishing experts and 200+ global customers.

Global eCTD Publishing and Submission Services formats, which Freyr can support are:

Health Authority by Country	Application and Submission Type	Submission Format	Freyr Support
Food and Drug Administration (FDA) USA	Investigational New Drug (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Biological License Application (BLA), Over the Counter (OTC), Drug Master Files (DMF Submissions), Structured Product Labeling (SPL) Submissions, and Supplemental New Drug Application (SNDA Submissions) Originals, Amendments, Annual Report Submissions, Labeling Supplement Submissions, Periodic Adverse Drug Experience Report (PADERS), Briefing Book, eCTD Baseline Submissions, Ad Promo Submissions, and eCTD Submissions for Lifecycle Management (LCM)	eCTD	Yes
European Medicinal Agency (EMA)	Centralized Procedure (CP), Decentralized Procedure (DCP), Mutual Recognition Procedure (MRP), and National Procedure (NP) Clinical Trial Application (CTA), Originals, Variations, AtoQs, Renewals, ASMF eCTD Submissions, and Medical Device Submissions	eCTD	Yes
Health Canada	New Drug Submission (NDS), Supplement to a New Drug Submission (SNDS), and Supplement to a New Drug Submission – Confirmatory (SNDS-C) Abbreviated New Drug Submission (ANDS) Supplement to Abbreviated New Drug Submission (SANDS)	eCTD	Yes
Swiss Medic	Initial submissions, Responses, and Variations	eCTD	Yes
Saudi Food and Drug Administration	New Market Authorization (MA), Renewals of MA and Variation, and Type 1 & Type 2 Responses to Questions Periodic Safety Update Report (PSUR) Submissions	eCTD	Yes
Ministry of Health (MOH) - Oman	New MA, Renewals of MA and Variation, and Type 1 & Type 2 Responses to Questions Periodic Safety Update Report (PSUR) Submissions	eCTD	Yes
Thailand Food and Drug Administration	Initials and Amendments	eCTD	Yes
Australian Therapeutic Goods Administration (TGA)	Market Authorization Application (MAA)	eCTD	Yes
Jordan Food and Drug Administration (JFDA)	Baseline Submissions and Initial Market Authorization (JO eCTD Module 1)	eCTD	Yes
National Medical Products Administation (NMPA)	Baseline Submissions, New Drug Applications, Generic Drug Application, and Clinical Trial Application (Module 2 to Module 5)	eCTD	Yes

Global eCTD Publishing and Submissions Services

Expertise
Advantages

Capturing and continuously updating region-specific HA requirements.
Converting documents from paper or NeeS to the compliant eCTD format.
Maintaining a repository of regional and global eCTD publishing standards
Regular training on evolving eCTD submission requirements
Gap analysis, process design, and tool-based documentation
Version tracking throughout the eCTD publishing lifecycle
Full deployment of Freya.Submit, a robust eCTD publishing tool

Skilled professionals with deep experience in eCTD Submissions
In-house eCTD publishing tools enabling automation and compliance
Full-spectrum electronic common technical document(eCTD) services lifecycle support
Dedicated regulatory resource planning and publishing strategy
Accurate document-level and report-level publishing using compliant eCTD format
Two-level quality checks and real-time submission monitoring
24/7 global support for uninterrupted Global eCTD Publishing and Submissions
Fast turnaround times and clear, transparent execution