The electronic Common Technical Document (eCTD) is a standardized electronic format used for submitting applications, amendments, supplements, and reports to regulatory authorities such as the United States Food and Drug Administration (USFDA), the European Medicines Agency (EMA), and other Health Authorities (HAs) worldwide. eCTD submissions streamline the creation and review of Electronic Regulatory Publishing data, offering the flexibility to incorporate metatags, hyperlinks, and bookmarks. This format enables efficient assessment and lifecycle management of submissions, ultimately expediting market approvals/authorizations.

With extensive expertise in global eCTD publishing trends and submission formats (e.g., eCTD/Non-eCTD Electronic Regulatory submissions [NeeS]), Freyr facilitates multi-country filings, data compilation, publishing, and dossier dispatch.

We have a team of experts proficient in a wide range of technologies including:

Insight Publisher, Validator
Veeva Vault RIM Suite (Submissions, Submissions Archive, Publishing), Veeva Vault Promomats & Veeva Quality Docs
Lorenz Docubridge, eValidator
Extedo EURS Validator
eCTDXpress
ISIS Publisher/Tollbox

Our team is equipped to provide comprehensive support across these technologies to meet your needs effectively.

Health Authority by Country Application and Submission Type Submission Format

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

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

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