There are two significant factors presently impacting the regulatory submission environment: first, the current necessity for Pharmaceutical & Biotechnology companies to focus their resources on
Marlborough, MA (PRWEB) January 13, 2009
Founder, President and CEO Shylendra Kumar of Datafarm, Inc. a leading provider of Electronic Document Publishing Solutions and Regulatory Submissions Services for the Life Sciences Industry, is pleased to announce the appointment of Mr. Daniel F. Orfe to Vice President, Global Regulatory Submission Services (GRSS). In this role, Mr. Orfe will oversee Datafarm's Regulatory Services Group. Additionally, Mr. Orfe will direct the company's electronic regulatory submission publishing and management activities; providing strategic support for the further expansion of Datafarm's Regulatory Submissions Services.
Mr. Orfe is a recognized industry leader in the field of Electronic Regulatory Submissions. Prior to joining Datafarm Mr. Orfe established and managed the Electronic Submissions group at Merck & Co., Inc. for over 10 years. His group located in the US, Canada, EU, and Japan produced in excess of 3000 eCTD s/eSubmissions annually for regulatory agencies worldwide. This group produced eCTDs for all NDAs, BLAs and INDs (and associated sequences) delivered to the US FDA CDER/CBER via the FDA Electronic Submission Gateway (ESG). Additionally, 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 activities to sharpen practices and reduce time to market. Strategically partnering with Datafarm's regulatory submissions group to completely or partially outsource submissions management processes and technology brings cost and time benefits. This is strengthened with faster time to market through rapid access to the right skills, adequate people resources, and the latest technologies coupled with extensive experience and an unrivalled reputation.
"Dan has been our end user since 1997, his regulatory affairs, operations and technical knowledge will help us to further expand our services group to better assist our customers," added Shy Kumar; "With a unique set of qualifications and experience, Dan is among a very select group of individuals who I would want in this position, and I know Dan will certainly give us his best in this new role to assist our customers around the world."
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.