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Expertise

Publishing

VCLS assists life science companies to streamline the entire submission process from preparing eCTD compliant files to publishing and submission.

With a global team of qualified publishers and a state-of-the-art publishing software, we effectively and efficiently manage your specific regional or global submission requirements to ensure timely delivery. The eCTD publishing for regulatory filing can be a time-consuming task which can result in a delay of the potential submission date.  VCLS is a “one-stop shop” to streamline and optimize your entire document creation value chain.

VCLS provides guidance on publishing strategy and submissions and support for the following types of applications:

  • US Investigational New Drug Applications (IND)
  • Global and Regional Marketing Applications: MAA, NDA, BLA, ANDA, NDS
  • Post-Approval : Amendments, Renewals, Variations, PSURs, etc.
  • Technical Baseline Applications
  • Redacted Documents in accordance with EMA  Policy-070
  • Active Substance Master Files (ASMF) and US Drug Master Files (DMF)
  • NeeS applications

Publishing support includes:

  • Assistance with identification of Regional requirements
  • Formatting Microsoft Word files
  • PDF rendition to eCTD compliant files
  • Bookmarks and inter-document linking
  • Technical Validation
  • Full technical Quality Control (hyperlinks, bookmarks, metadata )
  • Delivery of a technically compliant dossier in accordance with ICH Specifications and Regional Validation Criteria
  • Submission Management: FDA  Gateway, EMA Gateway, PSUR Repository, CESP, CD/Paper

F.A.Q

Does a Pediatric Investigation Plan submission need to be prepared and submitted in eCTD Format?

Pediatric Investigation Plans are not submitted in eCTD format.  The application is submitted as PDF files named in accordance with the Pediatric Investigation Plan guidance found here : https://www.ema.europa.eu/en/human-regulatory/research-development/paediatric-medicines/paediatric-investigation-plans and dispatched via the EMA Gateway.

  1. eCTD (electronic Common Technical Document) is a standard format of submitting Regulatory information (such as applications, supplements, and reports) to the concerned Health Authorities (HAs). It provides a harmonized solution to implement the Common Technical Document (CTD) electronically. An eCTD consists of individual documents in PDF format which are arranged in a hierarchical form as per the CTD structure. It also has an XML backbone which cross-links required documents and provides information regarding the submission.

There are 5 modules in the eCTD

  • Module 1 – Regional Information
  • Module 2 – Summary information (across CMC, Nonclinical and Clinical)
  • Module 3 – CMC data
  • Module 4 – Nonclinical Study data
  • Module 5 – Clinical data

Major countries, such as the US, Europe, Australia, Canada, South Africa, Thailand, Swiss, GCC, Jordan and Japan, are using eCTD as a standard format for product applications.

Health Authority by Country Application and Submission Type
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, 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, eCTD Submissions for lifecycle management (LCM)

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European Medicinal Agency (EMA)

 

 

 

 

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

Clinical Trial Application (CTA), Originals, Variations, AtoQs, Renewals, ASMF eCTD Submissions, Medical Device Submissions

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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)

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Swiss Medic

 

Initial submissions, Responses, Variations

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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) submissions______________________________________
Ministry of Health (MOH) – Oman

 

 

New MA, Renewals of MA, Variation Type 1 and Type 2 Responses to Questions,

Periodic Safety Update Report (PSUR) submissions

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Thailand Food and Drug Administration

 

Initials, Amendments

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Australian Therapeutic Goods Administration (TGA)

 

Market Authorization Application (MAA)

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Jordan Food and Drug Administration (JFDA)

 

Baseline Submissions, Initial Market Authorization
(JO eCTD Module 1)______________________________________

VCLS Expertise