One World, One Solution. Multiple options

ISI recognizes that it’s a complex world pharmaceutical companies operate in. While selling in multiple countries represents opportunities for drugmakers to offer medications to broader patient populations, each market comes with a unique set of regulatory challenges to overcome before drugs can be prescribed there.

For a pharmaceutical company looking to extend the lifecycle of a drug, navigating the varying multi-country submissions requirements can be daunting—and costly if not done in an efficient and compliant manner. For every day a drug launch is delayed due to rework, the losses equate to approximately $1.1 million daily in prescription revenue.

To help pharmaceutical companies successfully launch or expand therapies into new markets, ISI has enhanced the global support of its regulatory electronic publishing and paper publishing products to create one of the industry’s most powerful submissions solutions. eCTDXPress and ISIPublisher, the flagship products in ISI’s Regulatory Solutions Suite (RSS), are now used by the majority of the top 50 pharmaceutical and biotechnology companies worldwide.

The RSS offers one integrated solution with the functionality to create any submission format (eCTD, NeeS, ACTD and paper) as well as comply with evolving country-specific guidelines from within the same application, accelerating the time to market. Additionally, new requirements for both electronic and paper submissions in Australia, Japan, European Union and emerging countries such as China, India, and Russia are included.

RSS is built on Microsoft.NET framework and integrated with document management systems Microsoft Office SharePoint Server and Documentum. Integration with SharePoint Server offers a central platform for global collaboration on all data and documentation during the submissions process, shortening the submissions cycle and time-to-market.

The products included in RSS can be purchased and implemented as an end-to-end suite, or as standalone applications. Regulatory consulting, process services, tools and templates to support ISI’s products are included.

Products in the ISI Regulatory Solutions Suite:

eCTDXPress, for compiling, creating, publishing and managing electronic submissions in the eCTD format. As many countries transition to eCTD in 2010, ISI has upgraded eCTDXPress to accommodate the unique cultural, language and metadata guidelines of multi region eCTD submissions. eCTDXPress is the industry’s most proven, global submission solution.

ISIPublisher, seamlessly enables companies to publish all the regulatory documentation required in a paper or non-eCTD submission. Powerful report level publishing capability includes tables, appendices, figures, meta data and large-scale paper submissions. ISIPublisher has been upgraded to improve publishing support of attributes required by regulatory bodies in Europe, Australia, and Japan.

ISIRegTracker, for complete registration and licensing data management and tracking capability.

Virtual Link Manager (VLM), for efficient management of hyperlinks, stores hyperlinks in a database and automatically updates them in documents. VLM allows the user to finish the majority of the hyperlinking before submission date, while also supporting last minute creation of hyperlinking from within eCTDXPress.

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

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.