eCTD Publishing and Submission Services

Freyr ensures rapid global Regulatory approvals with expert eCTD Publishing services, leveraging in-house software, Freyr SUBMIT PRO, to support various submission formats, including eCTD and non-eCTD electronic submissions (NeeS).

For Regulatory Success, Contact Now!

Send us your details and we will get in touch.

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 CountryApplication and Submission TypeSubmission FormatFreyr 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

sahpra
[formerly known as MCC]

 

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)

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.

eCTD Publishing and Submission Services

  • Developing and maintaining the process of capturing and documenting the regional Health Authority (HA) requirements.
  • Paper to non-eCTD electronic submissions (NeeS) 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).

Comply with Global eCTD Formats

Partnering with Leading Organizations

 

Medicinal Products

Publishing and Submission

UK

I am sure you have heard by now that we have received our first-ever approval from the FDA for our Brands division. This is a major milestone for us as well as for my team here in Reg Ops. I would be remiss if I didn’t point out that we would not have been able to do this without the help of your dedicated team. From the original filing, then the following year of responses, all helped get us to final approval.

Thank you Freyr team for a job well done!

Michael Bellero

Sr. Director, Head of Regulatory Operations

 

Medicinal Products

Publishing and Submission

UK

We would like to appreciate Freyr’s quick TAT to push through an urgent submission required by the FDA. Their efficiency, diligence, excellence, sense of urgency, and priority are deeply flexibility.

Please keep up the great work as we have many milestones to achieve over the next year.

Ed Venkat

Global CMC Technical Lead

 

Medical Devices

Publishing and Submission​

USA

Communication and on the ground knowledge or RA requirements - this has been our experience for India. Quick to response and willing to have calls to explain requirements. Very happy with the RA work conducted in India, would use for other markets. We are satisfied. ​

Director of Regulatory Affairs​

France-based, Leading Global Supplier of Women Healthcare Products Company​