- ISI best placed to help meet the challenges presented by continually-evolving European standards -
Eschborn, German – October 28th , 2008 – Image Solutions Europe, a leading provider of software and services to streamline the regulatory approval process, today announced it has expanded its portfolio of services and outsourcing capabilities to help life sciences companies respond to the constantly evolving European standards around electronic submissions.
The European regulatory environment is complex and fast changing as the 27 countries that make up the European Union (EU) continually revise their approach to handling submissions. This evolving landscape was recently evidenced in the Czech Republic which originally mandated eCTD submissions from July 1st only to relax its guidelines in October accepting that the original mandate was impractical and leeway should be offered. All health authorities must be capable of receiving eCTD-only submissions by the end of 2009; however in the interim, pharmaceutical companies could be faced with creating different submission formats (eCTD, NEES, paper and sometimes in parallel) to meet the requirements of the EU member states.
“These are notoriously difficult waters to navigate and this has never been more true than now as drugs companies attempt to meet the requirements for electronic submissions from one country to the next,” said Kate Wilber, Senior European Regulatory Specialist at ISI. “Keeping track of the European submissions landscape is a full-time job. Staying on top of how many paper copies are needed or whether a pure eCTD submission is now acceptable in each country is almost impossible, simply because the situation is continually being revised.”
This increasing market interest in outsourcing of non-core activities stems from pharmaceutical organisations’ attempts to sharpen their practices and reduce time to market given the darkening economic climate and rising competitive pressures. Strategically partnering with regulatory specialists ISI to partially or completely outsource submissions management processes and technology brings cost and time benefits derived from the superior economies of scale that ISI brings to the table. This is strengthened with faster time to market through rapid access to the right skills, adequate people resources, and the latest technologies coupled with extensive experience and an unrivalled reputation.
For pharmaceutical companies that don’t have software in-house ISI offers fully outsourced publishing services and/or a Software as a Service (SaaS) alternative where the software and service is externally hosted and accessed on-demand leaving the pharmaceutical company to get back to its business. This is the option that global Pharma group Boehringer Ingelheim took with ISI last year investing in a SaaS delivery-based system, to help it meet an impending deadline for eCTD electronic submissions. FDA deadlines precluded using an in-house system (which would require extensive integration and the need for an entire team to be assembled to manage and support the technology). A further plus for Boehringer Ingelheim was that ISI offered it the flexibility to bring the technology in house if there came a point when this was deemed to be beneficial. The transition would be very simple, maintaining complete continuity of the systems being used, with any differences in output related purely to the change of location and ownership of the software and hardware. This offered Boehringer Ingelheim maximum flexibility.
“No single outsourcing blueprint will work for all companies or all types of submissions and at ISI we recognise that and offer a broad scope of services from consulting and partnering to partial or complete regulatory management outsourcing. That way, each company can select the level of service they need and ‘pick and mix’ accordingly,” adds Kate. “We have clocked up many years of experience partnering with clients to deliver these services and we have an unrivalled team of specialists in Europe to call upon to help pharmaceutical companies address whatever eCTD challenges they face.”
About ISI Services
ISI guides clients through their transition to eCTD by offering a full suite of services to get companies started with electronic submissions; help them build their knowledge base as well as their technology infrastructure; refine their regulatory processes; and prepare content for submission. Since each environment differs, the services provided by ISI are completely customized for each client. ISI has just won its first multi-year outsourcing project with a Top 15 global pharmaceutical company – the first regulatory operations outsourcing engagement in industry.
This achievement caps a successful growth trend for ISI. Since 2004 when ISI began offering complete submission services, the company has delivered more than 1,000 eCTDs. In addition, ISI has also successfully compiled in other formats, delivering thousands of paper, electronic, and non-eCTD electronic submissions, commonly called NeES. ISI has delivered multiple submission types across regions, including CTD, NDA, BLA, ANDA, IND, PMA, MAA, CTA, NDS, and DMF, and has also converted previous submissions to the CTD/eCTD format.
To find out more about ISI’s submissions outsourcing services please contact visit www.imagesolutions.com
Founded in 1992, Image Solutions, Inc (ISI) is a proven market leader in providing submissions solutions, process services and consulting to Life Sciences companies as a way to improve clinical and regulatory processes that bring new medicines to market. ISI was among the first professional services firm to deliver electronic submissions to the industry and since has delivered thousands of submissions. The company has a 49 percent market share among Top 50 global pharmaceutical for its flagship submission product, eCTDXPress, and 4 of the top 10 pharma now have ISIPublisher.
ISI is a privately held company with headquarters in Whippany, New Jersey and operations throughout the U.S., Europe and Asia. ISI also remains committed to giving back to society and sharing its success with others by donating 10 percent of annual net profits to over 20 recognized charitable organisations. For more information, visit the company website at www.imagesolutions.com.
Carina Birt, Sarum
PR for ISI
+44 1722 411150
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