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 |
|---|---|---|---|
| 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 |
| 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 |
| 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 |
| Initial submissions, Responses, and Variations | eCTD | Yes |
| New Market Authorization (MA), Renewals of MA and Variation, and Type 1 & Type 2 Periodic Safety Update Report (PSUR) Submissions | eCTD | Yes |
| New MA, Renewals of MA and Variation, and Type 1 & Type 2 Responses to Questions Periodic Safety Update Report (PSUR) Submissions | eCTD | Yes |
| Initials and Amendments | eCTD | Yes |
| Market Authorization Application (MAA) | eCTD | Yes |
| 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 |
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) 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)
