Boehringer Ingelheim Helped to Meet FDA Submission Requirements by ISI

A leading provider of software and services to streamline the drug development and regulatory approval process, Image Solutions, Inc. (ISI), announced today that world-leading global pharmaceutical group Boehringer Ingelheim has deployed the company’s flagship solution for managing and reviewing electronic submissions, eCTDXPress, via a Software-as-a-Service (SaaS) hosted model. The process from selection to implementation and validation took just under eight months.

The company was able, based on Boehringer Ingelheim’s decision to procure the software using the SaaS model, to comply with the electronic Common Technical Document (eCTD) format developed by the International Conference on Harmonisation. The United States is the first to require electronic submissions in eCTD, while many regulatory agencies are moving toward the eCTD-only format. As of January 1st 2008, the U.S. Food and Drug Administration (FDA) requires the eCTD format for electronic submissions, applicable for any pharma company targeting the U.S. market.

Comprising the relevant tools, global authoring templates, outsourced services, and software, ISI offers a range of flexible solutions that address this need. This can be ‘purchased’, crucially, as a hosted service, maximising speed of deployment, minimising the internal investment needed in infrastructure changes and skilled resources.

With particular interest in the most important territories Europe, Japan and the USA, Boehringer Ingelheim, headquartered in Ingelheim, Germany, develops and produces pharmaceutical products for human and animal health that are usually submitted for regulatory approval across the globe. USA consequently required their electronic submissions activities to be compliant with the new FDA regulations.

One of the crucial decision factors in finding the most appropriate software solution was whether it could be provided on a flexible SaaS basis. Precluding an in-house system that would require extensive integration and validation, and an entire team to be assembled to manage and support the technology, Boehringer Ingelheim had given itself until December 2007 to successfully implement the new solution.

The project started in April 2007 and was delivered on time by December 2007.

Boehringer Ingelheim, since first deploying ISI software for supporting electronic submissions over five years ago, has cut at least two weeks from the submissions cycle. For a blockbuster drug worth 1 billion euros a year, a two-week time-to-market acceleration is worth a lot.

Boehringer Ingelheim confirmed that it has been a very smooth collaboration with a rapid rollout and the timelines speak for themselves.