Solutions for eSubmission Readiness

In collaboration with

Current e-Submission Environment (agencies)

In July 2003, the Common Technical Document (CTD) came into effect in Europe, the U.S., Japan and Canada. The CTD harmonizes submissions [i.e., MAA, NDA, NDS] on a worldwide basis. Following the implementation of the CTD, there will be a rapid migration by regulatory agencies and industry to the new harmonized standards for the electronic Common Technical Document (e-CTD).

Current e-Submission Environment (companies)

Integrated electronic document and submission management can be used strategically to enhance the submission and review process

Yet many companies are reluctant to commit to fully electronic submissions and integrated processes. Investigation reveals glaring "gaps" in process that can inhibit timely efficient submissions.

Acquiring technology is typically viewed as more important than process development

This leads to purchased technology that fails to achieve expected business benefits. Technology alone cannot provide the confidence in your documentation that is required for electronic submissions and the related compliance activities (e.g. 21CFRp11).

How will electronic submissions affect you?

Your patent describes your technology, but your documents define exactly what you have done and how your research has been proven. The value of the company is in both your patents and your documents. The value of your electronic documents is in your ability to easily update them, access them and use them as submission documents or as source material for document development. The documents that you produce today (for INDs, for your partners etc.) form the basis of future marketing applications.

Getting started

We can provide a standard methodology that will assist companies to achieve readiness for e-submissions. In a relatively short time, we can work with your company to develop the strategy, processes and procedures required to ensure robust electronic versions of documents through good document management practices. Examples of processes and procedures that we can customize to your specific needs are:

• Managing and Authoring Documents
• Managing Documents from Contract Organizations
• Managing Templates
• Standards and Formats for Reports
• Filing and Records Management
• Archiving Electronic and Hard Copy Documents

Who Will Benefit from our Approach

Pharmaceutical companies

Emerging biotech firms:

• That may be new to commercialization
• That are beginning to author and prepare documents for submissions
• Who have products scheduled for submissions within 12 to 18 months
• Who want to ensure robustness of documents for electronic submissions

Contract Research Organizations

What our clients are doing to get ready for electronic submissions

"In anticipation of the implementation of the e-CTD, we are enhancing our ability to develop submissions electronically. This involves technical improvement in our document management and submission production processes. The implementation of a wide area network will enable the efficient and secure transfer of documents between our clients and us"