KOWA Achieves Their First eCTD Submission with Datafarm's eCTD Solution

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Datafarm, a leading provider of Electronic Document Publishing Solutions and Regulatory Submissions Services for the Life Sciences Industry, is pleased to announce the successful collaboration with KOWA Research Europe, Ltd (KRE), in completing KOWA's first Marketing Authorization Application in the eCTD format.

Datafarm, a leading provider of Electronic Document Publishing Solutions and Regulatory Submissions Services for the Life Sciences Industry, is pleased to announce the successful collaboration with KOWA Research Europe, Ltd (KRE), in completing KOWA's first Marketing Authorization Application in the eCTD format.

In August 2008, Datafarm and KOWA joined forces to complete their largest decentralised (DCP) submission in history. The DCP included 520 volumes, 1100 compact discs and approximately 275,000 navigational aids (bookmarks and hyperlinks). This complex submission incorporated the new EU Module 1 Specification/DTD Version 1.3 that was released in May 2008. Datafarm used its industry leading software applications, including a-Pulse® and experienced regulatory consultants to ensure the documents were compliant, before being compiled into the eCTD using eCTDBuilder® and S-Cubed®.

Jasbir Chohan, Associate Director Regulatory Services, said "It has been a pleasure to partner with KOWA on this project. It has been an exciting project to be involved in, not only due to its complex nature, but also because we were able to help KOWA successfully submit their first ever eCTD submission. Through the use of our global publishing resources we provided 24 hour regulatory support and ensured that KOWA achieved success in their submission process."

Bryan Carter, Head of Regulatory Affairs, KOWA, said "This was our first eCTD submission, and due to its size and complexity we needed a partner with an excellent combination of eSubmission products, strong regulatory expertise and who was focused on the pharmaceutical industry. We wanted a partner that didn't just sell us products, but was willing to work alongside us for mutual success. We found that in Datafarm."

KOWA Research Europe, Ltd. (KRE), established in 1999 in the United Kingdom, is managing European clinical trials for Kowa's strategic global pharmaceutical development. The primary therapeutic areas being focused upon are cardiovascular and related conditions (e.g. diabetes), anti-inflammatory conditions (R.A), dermatology and ophthalmology.

About Datafarm, Inc.: Established in 1997, Datafarm is a leading provider of Regulatory Submission software and professional services solutions for the Life Sciences industry. Datafarm provides custom and off-the-shelf software solutions that produce high-quality and agency-compliant e-Submission-ready documents to customers worldwide. To date, the company's products have been used to compile thousands of eSubmissions. Datafarm's professional services team has partnered with industry sponsors to submit hundreds of eSubmissions to the USA, Canada, European Union, and Japanese regulatory authorities. Headquartered in Marlborough, Massachusetts, USA, Datafarm has regional offices in California, the UK, France, and India. Information about Datafarm's products and services can be found at http://www.datafarminc.com.

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Steven Mckinlay
Datafarmin, Inc.
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