ISI recognizes that the regulatory landscape has become increasingly complex as different countries and regulatory bodies develop varying standards and formats related to eSubmissions. At the same time, Life Science organizations reluctant to embrace new technologies are concerned that the IT will become outdated or will not be able to support changes in the guidance over time. Many companies also recognize that they may require external expertise to help manage the submission process. As a result, ISI has developed a flexible solutions platform that can quickly accommodate new standards and adapt to unique client situations.

ISI’s pragmatic, scalable solutions take into consideration varying regions, regulatory agencies and changing electronic submission requirements. Our portfolio of industry proven tools and templates supports ISI’s flagship products, eCTDXPress® and ISIPublisher® and make up what we refer to as The ISI Regulatory Suite. The capabilities of ISI products are further extended through a flexible technology foundation – the ISI Solutions Platform.

ISI also leverages a deep history of providing process support, seamlessly blending product and service capabilities into powerful solutions. ISI provides a range of consulting services that can help companies navigate new regulations, as well as process services that can help fill internal resource gaps while the organization gets up to speed on the requirements, whether it’s short term for a particular submission or longer term.

With a record of accomplishment unsurpassed in the industry, ISI has a 15-year history of on-time submission success with over 600 eSubmissions and more than 350 eCTDs. That’s why the top 50 Pharmaceutical and Biotechnology organizations worldwide are ISI customers.

And because ISI manages the submission process for the majority of the top 50 Pharmaceutical organizations, ISI products are reliable and flexible enough to meet real-world submission challenges.

The ISI Regulatory Suite

The ISI Regulatory Suite includes a powerful set of applications and tools and templates built on a flexible, scalable foundation – the ISI Solutions Platform as  well as process services.

eCTDXPress – the most sophisticated submission software available, the eCTDXPress product line supports information gathering, submission development and cross-functional review, as well as publishing and archiving needs.

ISIPublisher – designed to enhance and streamline paper-publishing operations, ISIPublisher allows users to publish reports, submissions, or any electronically available documents that require professional printing. In addition, ISIPublisher also supports non-eCTD electronic submission assembly when integrated with eCTDXPress.

ISI Tools & Templates – productivity tools and templates that simplify and streamline workflow and extend the reach of the information contained in submission systems.

ISIRegTracker – helps overcome the challenges of keeping products on the shelf with attributes that manage and help update product registration data. ISIRegTracker allows users to manage information through an intelligent repository; increase productivity through project management features; and identify needs and track changes through convenient search and report capabilities.

Process Services – ISI offers process-based services to facilitate and expedite regulatory submissions, and to support the management of clinical trial data. Services related to electronic and paper submissions include: assembly, document processing, archiving and imaging, as well as hosting of eCTDs and CRFs.

Regulatory Consulting – Increasing the regulatory knowledge base throughout an organization and among other preferred outsourcing partners is the key to achieving best practice results. Most sponsors are  not able to keep up with the rapidly changing submission guidelines and regulations. However, submissions are ISI’s core competency, and helping companies keep up with the changes in regulatory environments is our business. Our services empower companies to benefit from our expertise.