Overview

eCTD (electronic Common Technical Document) is an electronic format that supports the submission of applications, amendments, supplements and reports to the FDA, EMA and other Health Authorities (HAs) worldwide. It also streamlines the submission process by facilitating the creation and review of electronic data, lifecycle management, and the exchange of information. By integrating the metatags, hyperlinks and bookmarks to the data, it also enables efficient assessment and navigation of Regulatory information that leads to faster reviews by HAs, thus enabling quicker market approvals/authorizations.

With a comprehensive knowledge of global Regulatory publishing trends and submission formats (for example eCTD/Non-eCTD electronic submissions [NeeS]), Freyr supports dossier submissions across the globe. For efficient, effective and multi-country filings, Freyr offers data compilation, data publishing and dossier dispatches through an in-house Regulatory publishing and submission software, Freyr SUBMIT, that supports global HA submission formats. Adhering to the United States Food and Drug Administration (USFDA), ICH HL7 standards, Freyr is a strategic partner for multiple submissions within brief timelines, which has proven to be very cost-effective for organizations.

The global eCTD formats, which Freyr can support are:

Health Authority Country Application and Submission Type
Food and Drug Administration (FDA) for 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)

Originals, Amendments, Supplements, Annual Reports, Periodic Adverse Drug Experience Report (PADER), Briefing Book

European Medicinal Agency (EMA)

Centralized Procedure (CP), Decentralized Procedure (DCP), Mutual Recognition Procedure (MRP), National Procedure (NP)

Clinical Trial Application (CTA), Originals, Variations, Answer to Questions, Renewals 

Health Canada

New Drug Submission (NDS), Supplement to a New Drug Submission (SNDS), Supplement to a New Drug Submission – Confirmatory (SNDS-C)

Abbreviated New Drug Submission (ANDS),

Supplement to Abbreviated New Drug Submission (SANDS)

Swiss Medic

Initial Submissions, Responses, Variations

Saudi Food and Drug Administration

New Market Authorization (MA), Renewals of MA, Variation Type 1 and Type 2

Responses to Questions,

Periodic Safety Update Report (PSUR)

Ministry of Health (MOH) - Oman

New MA,

Renewals of MA, Variation Type 1 and Type 2

Responses to Questions,

Periodic Safety Update Report (PSUR)

Medicines Control Council (MCCZA) SOUTH  AFRICA

MAA, Originals, Renewals

Taiwan Food and Drug Administration (MOPH) THAILAND

Initials, Amendments

Australian Therapeutic Goods Administration (TGA)

Market Authorization Application (MAA)

The Chinese Food and Drug Administration (CFDA) has announced that eCTD will become mandatory for e-submissions within China by 2018. Life Sciences organizations who have not yet began preparing for the new Regulatory requirements are advised to act quickly to meet the upcoming deadline.

 

Freyr Expertise

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

Freyr Advantages

  • A team of qualified publishing and submission supported by a sophisticated publishing and submission software – Freyr SUBMIT
  • Creating a submission roadmap:  right from compiling original submissions to maintaining the lifecycles, to regulatory resource allocation and support
  • Report level publishing, document-level publishing
  • 24x7 global delivery model
  • Transparent processes
  • Quick turnaround time (TAT)
  • Faster time to gain approval
  • Two-stage quality check process
  • Audit-ready submissions that are cost-effective and time saving solutions that enable your organization to focus on core business functions