## [Global eCTD Publishing and Submission Services](/medicinal-products/global-ectd-publishing-and-submission-services) # 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](https://www.ectdtool.com/?__hstc=189157428.9a347e0e495166ed15ee5bfd05f88aff.1744611933261.1755242044037.1755257382935.139&__hssc=189157428.6.1755257382935&__hsfp=2879002102), 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. - [Overview](#overview) - [Expertise & Advantages](#expertise) - [Testimonials](#testimonial) - [Insights](#insights) ## 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](https://www.ectdtool.com/?__hstc=189157428.9a347e0e495166ed15ee5bfd05f88aff.1744611933261.1755242044037.1755257382935.139&__hssc=189157428.6.1755257382935&__hsfp=2879002102), 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]() 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)]() 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]() 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]() Swiss Medic | Initial submissions, Responses, and Variations | eCTD | Yes | | ![Saudi Food and Drug Administration]() 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]() 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]() Thailand Food and Drug Administration | Initials and Amendments | eCTD | Yes | | ![Australian Therapeutic Goods Administration (TGA)]() Australian Therapeutic Goods Administration (TGA) | Market Authorization Application (MAA) | eCTD | Yes | | ![Jordan Food and Drug Administration (JFDA)]() Jordan Food and Drug Administration (JFDA) | Baseline Submissions and Initial Market Authorization (JO eCTD [Module 1](http://www.jfda.jo/EchoBusV3.0/SystemAssets/Documents/AR/DRUGD/JFDA%20Module%201%20Specifications_v_1.0.1-2018-11-28.pdf)) | 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](#mdv-1) - [Advantages](#mdv-2) - 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*](https://www.ectdtool.com/?__hstc=189157428.9a347e0e495166ed15ee5bfd05f88aff.1744611933261.1755242044037.1755257382935.139&__hssc=189157428.6.1755257382935&__hsfp=2879002102), 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 ![]() #### Comply with Global eCTD Formats [Consult Freyr](javascript:void(0))