Electronic Submission Expertise
Regulatory eSubmissions, LLC
Selected Merck & Co., Inc. Accomplishments
Selected Datafarm Inc. Accomplishments

Our History

Daniel F. Orfe is a Senior Leadership professional with 20+ years experience in Regulatory eSubmission production and 30+ years experience in support of the Life Science industry.  Dan is recognized within the industry as an executive level change agent and business process analyst for efficient submission assembly, dossier management and eCTD/eCTD life-cycle production and management.  

He has been a key member of several industry/agency initiatives to foster electronic submission standardization and efficiency.  Valued for his experience on the topic of eSubmissions, Dan has presented or chaired sessions at 10 of the past 11 DIA Annual Meetings and was conference co-chair for the DIA Electronic Document Management (EDM) Conference in 2009, 2010 and 2011. 

Dan was responsible for the establishment and management of eSubmission production groups at Merck & Co., Inc. and Datafarm Inc.   Areas of expertise include regulatory submissions strategy and business / technology process improvements; uniquely adept at identifying innovations which facilitate the automation of activities for efficiency and error reduction.  He has been particularly effective in transitioning organizations from strategic goals to tactical operations, with a special talent in building collaborative relationships across disciplines – both internally & externally – to deliver measureable results. 

Dan established and managed the Electronic Submissions group within the Worldwide Regulatory Operations department at Merck.  This group of 10 people located in the US, Canada, EU, and Japan produce over 300 eCTD/eSubmission deliverables per month. 
Merck’s achievements within this field established the team as an industry direction setter and submission delivery record setter and is widely praised and complemented both by industry peers and regulatory agencies. 

Dan oversaw Datafarm's Regulatory Services Group; directing the company’s electronic submission publishing and management activities; and providing strategic support for the further expansion of Datafarm's Submission Services.

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