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Regulatory product expansion for European pharmaceutical market

Image Solutions : 26 March, 2009  (New Product)
ISI has expanded on its ability to provide regulatory solutions for pharmaceutical companies in Europe for compliance
Image Solutions Inc (ISI) has emerged as the best positioned regulatory solutions supplier to meet the needs of European pharmaceutical companies.

ISI is now the partner of choice for European life science companies, thanks to what is now recognised to be the largest and broadest, in-depth suite of solutions and services available. Specifically, ISI is the only software provider to address the diverse range of submissions requirements across and beyond the EU, where eCTD timelines still vary enormously, creating a burdensome workload for submissions managers and under-resourced affiliate organisations.

While, in the US, submitting new drug licence applications in the eCTD (Electronic Common Technical Document) format is now the standard, the situation is more complex across Europe. Although most health regulatory authorities in the European Union are moving towards eCTD adoption, the exact requirements, formats and timelines vary considerably across national borders. Many countries still accept non-eCTD electronic submission, and may still require paper as the legal basis for submission. Many other countries are still firmly entrenched in paper submissions processes.

This is where ISI's market-leading global submission solution, the ISI Regulatory Solutions Suite, comes in. This unique, integrated solution suite allows companies to create documents in any submission format, which comply with evolving country-specific guidelines from within the same application. This dramatically reduces the amount of re-working needed, accelerating time to market.

To accommodate the need to submit to any country in any format through a single, integrated software solution, ISI has recently updated its flagship electronic publishing and paper publishing applications, eCTDXPress and ISIPublisher, with enhancements and additions that create one of industry's most powerful global submissions management systems. These additions allow European pharmaceutical companies to build eCTD submissions, while at the same time creating paper common technical documents (CTDs), non-eCTD Electronic Submissions (NeeS), and hybrid submissions.

Built on the Microsoft .NET framework and integrated with popular document management and collaboration environments such as Documentum and Microsoft Office SharePoint Server, the ISI solution set ensures maximum control over electronic content handling and sharing.

"For maximum flexibility, organisations can choose to purchase and run the ISI Regulatory Solutions Suite (RSS) as an end-to-end application portfolio, or as a selection of standalone desktop applications," notes European MD, Adam Sherlock, who now sits on ISI's Board of Directors. "Although modular in structure, the ISI suite has been built with a holistic approach, encouraging and helping organisations to adopt a comprehensive strategy to submissions, even as new formats (such as RPS) are introduced further down the line."

With more robust metadata now incorporated into the suite, companies have the building blocks in place for more effective information management. In one example, re-use of document management metadata reduced eCTD assembly of a selection of study reports from 48 minutes down to just four minutes - a 12-fold improvement!

To survive in today's challenging economic climate, leading organisations must have a global strategy in place to target markets where the demand is greatest. For pharmaceutical companies looking to create new revenue streams or supplement existing ones, selling products in multiple geographical markets presents a valuable opportunity to extend a drug's lifecycle and profitability.

"With its comprehensive, enhanced solution suite, supported by a range of professional services including outsourcing options, ISI is in a prime position to help international life sciences companies through this latest set of regulatory challenges, so that they can return their own focus to their core business activities," Sherlock concludes.
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