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Datafarm, Inc., Announces the Appointment of Daniel F. Orfe to Vice President, Global Regulatory Submission Services
Date:1/13/2009

ly, eCTDs were assembled and delivered to Health Canada, EMEA and other EU agencies, Japan (MHLW) and Australia (TGA). The group is recognized by peers and regulatory agencies as an industry direction setter and submission delivery record setter. Mr. Orfe has been a technical representative to the PhRMA ERS Working Group for the past 10 years. He was responsible for the creation and successful activities of the PhRMA ERS Division of Scientific Investigation (DSI) and Financial Disclosure sub-teams. He has participated as a speaker and session chair at the Annual DIA Conference for 5 of the past 6 years and is the Program Chair for this year's DIA EDM Conference.

Mr. Orfe said, "There are two significant factors presently impacting the regulatory submission environment: first, the current necessity for Pharmaceutical & Biotechnology companies to focus their resources on "core" business activities, and secondly, the movement of regulatory agencies towards an all electronic regulatory submission environment. These two dynamics, dictate an increasing role for regulatory submission services providers as strategic partners for submission management, assembly, delivery, access, and archive capabilities. I am delighted to join Datafarm, a company whose history in electronic submission publishing, assembly and delivery products coupled with an established reputation as a regulatory submission services industry leader uniquely qualifies them to collaborate with life science organizations to address their vital regulatory submission services needs."

The darkening economic climate and rising competitive pressures within the life sciences industry has increased interest in outsourcing of submission preparation and life cycle management ac
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