Whippany, NJ (June 2 , 2006) - Image Solutions, Inc., (ISI) a global technology company and leader in providing software and services solutions for electronic regulatory submissions and clinical trials management to Pharmaceutical and Biotechnology sponsors worldwide, today announced that they have completed an exclusive partnership agreement with The Synapse Partnership.
The Synapse Partnership, a UK regulatory software specialist located in Cheshire, UK and ISI, have signed an exclusive global distribution agreement, awarding ISI the rights to market and distribute RegTracker software. The partnership between the companies brings together two of the leading products for pharmaceutical regulatory affairs management and tracking by strengthening ISI’s established flagship eSubmission software product ‘eCTDXPress’ and offering an integrated solution for managing, and submitting drug approval applications to regulatory agencies worldwide with the addition of RegTracker.
ISI has pioneered electronic submission and document management tools since 1992, and now offers a wide range of products and service solutions to Pharmaceutical and Biotech organizations all over the world. ISI’s flagship product, eCTDXPress® 2.3, is a web-based solution for creating, managing and reviewing electronic submissions in the global standard "electronic Common Technical Document" (eCTD) format.
RegTracker is a web-enabled software application that enables clients to efficiently manage the marketing authorization procedure. Providing a central repository for global product registration information, it features powerful project management, search, reporting and publishing capabilities to manage registration and compliance issues throughout the regulatory lifecycle.
The Synapse Partnership’s CEO, Adam Sherlock, emphasized the synergy between the two companies and products, “This is an exciting opportunity for both companies – we are both highly active in the regulatory affairs sector and share the same ‘customer-led’ philosophy, developing innovative products that respond to changing customer needs. Increasing demands for regulatory compliance are driving demand for a global sharing of data and more efficient management of the regulatory process. ISI’s eCTDXPress and Synapse’s RegTracker are complementing web-based solutions that integrate to provide streamlined management of the regulatory life cycle, delivering true user benefits in terms of improved productivity, efficiency and time-to-market.”
ISI’s CEO Jinsoo Kim adds, “ISI is committed to continually adding new products and services to our already strong portfolio, and with RegTracker we continue to follow our ‘best-in-class’ technology approach. We are extremely enthusiastic about the opportunities that this partnership will offer and are extremely confident that RegTracker will make a valuable contribution to the regulatory affairs business.”