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News

Pilgrim partners Virtify to provide Electronic Regulatory Submissions solution

Pilgrim Software : 18 September, 2008  (Company News)
Pilgrim Software has formed a strategic partnership with Virtify to jointly provide an Electronic Regulatory Submissions solution for complete lifecycle management of the regulatory submissions process.
Together, Pilgrim and Virtify will support the submissions efforts of enterprises, from emerging growth companies with a single product, to global companies issuing submissions in dozens of countries with different format requirements. Pilgrim’s Regulatory Submissions solution enables electronic submissions to speed manufacturers’ product approvals and time to market.

The joint offering is based on industry-leading applications, built on Microsoft .NET and XML technology: Pilgrim’s SmartDoc document management solution integrated with Virtify’s Virtx eCTD platform.

“As a solution provider to the Life Sciences industry for over a decade, Pilgrim recognized the growing complexities of the regulatory submissions process, particularly today when many companies are still using manual, paper-based processes even though the era of mandatory electronic filing is upon us,” said Nikki Willett, vice president of marketing and regulatory affairs for Pilgrim Software. “Companies need to put the focus where it belongs squarely on delivering final submissions that can handle the complex, ever-evolving landscape of the Life Sciences industry. That’s why we’ve partnered with Virtify, a leader in standards-based submissions, to reduce the complexities and accelerate the submissions process lifecycle.”

The Regulatory Submissions solution provides all the elements needed for eCTD or non-eCTD electronic submissions (NEES), and will help organizations prepare for the global mandates by regulatory agencies.

Using this offering from Pilgrim and Virtify, companies will gain complete control over the submission document lifecycle, from streamlining submission planning, preparation and tracking, to high-quality and seamless assembly and publishing. The web-based automated product also ensures improved quality control and timely distribution.

“Virtify’s vision is to provide people with the software tools that will enable them to collaborate and work in an integrated environment that’s based on evolving standards,” said Satish Tadikonda, president of Virtify. “Pilgrim shares that vision, so in partnering with Pilgrim to provide the Regulatory Submissions solution, we’re enabling companies to take on the evolving regulatory landscape and strengthen their ability to meet both the challenges and the opportunities for success in the Life Sciences Industry.”
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