1 December, 2009 — Datafarm Inc., a world-leading provider of high
performance electronic regulatory submission solutions for the life sciences industry, today
announced the availability of the API package, a comprehensive electronic regulatory
submissions software solution for generic drug companies.
George Waidell, vice president of sales and marketing at Datafarm said, “Since 2007, when the
FDA announced the Generic Initiative for Value and Efficiency (GIVE) which intends to amplify
the quantity and selection of generic pharmaceutical products that are available, the stakes
have gone up for generics companies. These companies are faced with the same challenge of
meeting requirements for regulatory submissions as the traditional pharma companies,
however, their journey towards compliance differs due to the need to meet bioequivalence.
Datafarm acknowledges these differences by designing a feature rich package at a very cost
effective price point.”
The API package is specifically designed to enable generics pharmaceutical companies in the
production of electronic regulatory submissions, which must demonstrate therapeutic
equivalence to a specified, previously approved reference listed drug. The API Package has all
the utility of Datafarm’s state-of-the-art electronic submissions technology including authoring,
publishing, compilation and viewing at a price point that matches the value proposition for
generic drug organizations. For more information about the API package please visit:
www.datafarminc.com.