Expertise

e-Publishing

VCLS assists life science companies to streamline the entire submission process from preparing eCTD compliant documents to electronic publishing and submission through Health Authority Gateways.

Health Authority Portals:

Electronic submissions Gateway (ESG)
Webtrader
CDER NetGen Portal
CDER Direct
FEI Portal

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. 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), Amendments and Annual Reports/DSURs
Global and Regional Marketing Applications: MAA/NDA/BLA/ANDA/IND
Post-Approval: Renewals, Variations, PSURs, Annual Reports (IND, NDA, BLA, DMF, VMF, ODD), Prior Approval Supplements, CBE-30, CBE-0, PADERs
Technical Baseline Applications
Redacted Documents in accordance with EMA Policy-070
Active Substance Master Files (ASMF), US Drug Master Files (DMF) / Veterinary Master Files (VMF) and related amendments/updates
Non-eCTD Electronic Submission (NeeS) applications

Mandatory for EU:

Labeler Code Requests, Establishment Registrations and Drug Listings
Structured Product Labeling (SPL) preparation and submission

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 ESG Gateway, EMA Gateway, PSUR Repository, CESP, CD/Paper
Delivery confirmation with receipts and acknowledgement from Health Authorities

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.

What is an eCTD submission?

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 that 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

What countries / regions accept eCTD submissions?

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.

Which applications can I submit in eCTD format?

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)______________________________________

e-Publishing

Health Authority Portals:

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

Mandatory for EU:

Publishing support includes:

Public Access to Clinical Data: The evolution of initiatives from the European Medicines Agency

F.A.Q.

VCLS Expertise

Regulatory Strategy & Submissions

Access to Market

Due Diligence