eCTD Publishing and Submission Services

Freyr's global eCTD publishing and submissions team excels in Regulatory submissions using our in-house Freyr SUBMIT PRO software for eCTD compliance. We offer a seamless submission process, comprehensive tracking, detailed planning for major submissions, and health authority-recommended file naming. Our services include rigorous QC, efficient dispatch, and archiving. Benefits include fast turnaround, last-minute and ad hoc support, dedicated short-term and long-term assistance, onshore/offshore resources, a global team, technical project management, and seamless system migration, ensuring synergy throughout the entire submission process.

eCTD Publishing and Submission Services - Overview

The electronic Common Technical Document (eCTD) is an electronic format that supports the Regulatory submission of applications, amendments, supplements, and reports to the United States Food and Drug Administration (USFDA), the European Medicines Agency (EMA), and other Health Authorities (HAs) worldwide. eCTD submissions facilitate the quick creation and review of electronic Regulatory publishing data with the flexibility to integrate metatags, hyperlinks, and bookmarks into the data. The eCTD enables efficient assessment and effective lifecycle management of eCTD submissions for quicker market approvals/authorizations.

With a comprehensive knowledge of global eCTD publishing trends and submission formats (for example eCTD/Non-eCTD Electronic Regulatory Submissions [NeeS]), Freyr supports multi-country filings, data compilation, data publishing, and dossier dispatches. For faster, compliant, and seamless Regulatory submissions, Freyr offers eCTD publishing services using an in-house eCTD publishing and submissions management software, Freyr SUBMIT PRO, which adheres to the regional and ICH standards.

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

The National Medical Products Administration (NMPA) [formerly the CFDA] has announced that the eCTD submission format will soon become mandatory and will be in force from the first quarter of 2019. Life Sciences organizations that have not yet begun adopting the new NMPA eCTD Regulatory requirements are advised to act quickly for a smooth transition.

Developing and maintaining the process of capturing and documenting the regional Health Authority (HA) requirements
Paper to non-eCTD electronic submissions (NeeS) and to eCTD format conversions
Develop a knowledge repository for regional requirements across the globe
Periodic training and updates on the ever-changing global eCTD publishing and submission requirements
Gap analysis to create the process aids, charts, etc.
Continuous project monitoring
Periodic quality check for effective time management
Detailed tracker creation to track all the version changes made through the eCTD publishing lifecycle
Freyr SUBMIT PRO – an in-house Regulatory Publishing & Submissions eCTD tool

A team of qualified eCTD publishing and submission experts
A robust global eCTD publishing and submission services software
eCTD submission services roadmap right from compiling original Regulatory submissions to maintaining lifecycle
Regulatory resource allocation support
Report-level publishing and document-level publishing
Error-free eCTD submission services that enable your organization to focus on core business functions
Two-stage quality check process
24x7 global delivery model
Transparent processes
Quick Turnaround Time (TAT)