Friday 09 July 2010

Opening Pandora's box - a discussion on opening your Regulated systems to the outside world?

Friday 09 July 2010

“The challenges of Market Access” Marc Czarka

Friday 09 April 2010

Areas of expertise / Processes

eCTD - Electronic submissions

Implementation of a system for publishing and tracking the lifecycle of dossiers (dossiers or reports, CTD paper format/eCTD/NeeS, etc.) for all documents in the dossier to be submitted (modules 1 to 5).

Client objectives

• Compliance with the eCTD or NeeS electronic submission standards
• Reduce time required to prepare dossiers

Assignments carried out by the Consulting division of Product Life

• Consulting, educating and training in the area of eCTDs
• Editing strategies for legal and regulatory documents
• Support in the filing of electronic submission dossiers

Assignments carried out by the Services division of Product Life (for each submission/publication)

• Document editing
• Document verification prior to submission
• Reformatting of nonconforming documents
• Creation of document templates
• Assembly, validation and publication in all formats

Training

We have drawn on our extensive experience in the implementation of eCTD submission to define a number of guidelines for formatting and editing documents. We teach these guidelines to our clients in specific training courses. The aim of these sessions is to create a high-quality eCTD of a standard that will be accepted by the regulatory authorities.

• General introduction to eCTDs

• Practical session on creating an eCTD document

• Implementation of an eCTD project in the company

Product Life's presence on the eCTD market

In 2005, Product Life assisted the French regulatory agency AFSSAPS in defining, implementing and finding volunteer companies for its pilot eCTD submission project.  The aim of this pilot project was to convert the submission process to a paperless process, from receipt of the dossier to the final recommendation, including archiving in accordance with legal requirements.

Since 2005, Product Life has carried out eCTD-related assignments for more than 20 clients.