Read Electronic Submission To FDA eSubmissions as a Services text version

eCTD Preparation (NDA, ANDA, DMF) SPL Preparation (Facility Registration, Labeler Code Request, Drug Listings)

Team Tranquil Inc, eSubmissions as a Service

FDA Electronic Submissions

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eCTD Overview

The electronic Common Technical Document (eCTD) has become the standard for numerous regulatory agencies across the world.

The European Union has declared that its 27 Member States must be capable of accepting electroniconly marketing applications in the eCTD format, starting in 2009, and Health Canada has implemented an electronic review environment for eCTD submissions. Since 2006 our well experienced team at Team Tranquil prepared and helped submitting over 150 successful electronic submissions to FDA in eCTD format for various types of applications such as NDA, ANDA and DMFs. Some of these submissions already received approval from the agency. Team Tranquil is maintaining 100% success with electronic submissions. So far none of the submissions prepared by us received RTF from the agency.

Team Tranquil Inc, eSubmissions as a Service

FDA has mandated the eCTD format for electronic submissions to the Center for Drug Evaluation and Research (CDER).

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eCTD: Our Role ...

Team Tranquil will help our clients understand the standards and guidelines setup by various agencies. Prepare subsequent sequences for each application such as amendments, supplements, annual reports etc.

Prepare final submission media and help test the submission for accuracy of links within the submission or across submission sequences.

Help maintain proper structure for various modules in submission. Help create bookmarks and links in PDF documents

Prepare XML backbone for total submission including regional xml, index xml, study tag files, SPL (structured product labeling)

Help maintain redundancy of documents within a submission or across all sequences of an application

Team Tranquil Inc, eSubmissions as a Service

Help prepare the documents compatible for electronic submissions

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SPL: Overview

Structured Product Labeling (SPL) is a document markup standard approved by Health Level 7 and adapted by FDA as a mechanism to exchange product information. Ever since FDA released SPL version 4 guidelines it has been made mandatory to submit Facility Registrations, Labeler Code Requests and Drug Listings in SPL format. Team Tranquil is helping pharmaceutical companies prepare and submit product labeling in SPL format since 2005

Team Tranquil Inc, eSubmissions as a Service

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SPL: Our Role ...

We will help our clients obtain and setup E-Mail ID to be able to communicate with FDA.

We will make sure proper versioning of SPL documents were maintained and help in submission of annual Drug Listings of all approved products.

Team Tranquil help convert the labeling documents in SPL format for our clients.

We will prepare Facility Registrations in SPL format and help submitting the SPL through ESG web site.

We will prepare NDC Labeler Code requests

Team Tranquil Inc, eSubmissions as a Service

We will help setup Electronic Submissions Gateway (ESG) Accounts.

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Information

Electronic Submission To FDA eSubmissions as a Services

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