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

Selected Merck & Co., Inc. Accomplishments
  • Produced over 2000 eCTDs annually for all NDAs, BLAs and INDs (and associated sequences) delivered to the US FDA.
  • Established a global team which assembled and delivered over 1000 eCTDs annually to Health Canada, EU EMEA, Japanese MHLW and Australian TGA.
  • Established a common submission assembly hardware and software environment which is used by all submission assemblers regardless of global region enabling staff flexibility and support simplification.
  • Established the use of the FDA Electronic Submission Gateway (ESG) and attained status as a leading provider of eCTDs to the FDA via the ESG.
  • Developed and implemented standards to facilitate and automate the submission assembly process, i.e. citation constructs, folder/file naming conventions and SAS Transport file/define file conventions; thereby enhancing submissions quality and production throughput.
  • Participated as Merck's technical representative to the Pharmaceutical Research and Manufacturers of America Electronic Regulatory Submission (PhRMA ERS) Working Group for 10 years (1998 through 2008).  Responsible for the creation and successful activities of the PhRMA ERS Division of Scientific Investigation (DSI) and Financial Disclosure subteams.
  • Participated as a speaker and/or session chair at Annual DIA meetings (2003, 2004, 2005, 2006 and 2008).  Additionally, presented at other DIA conferences.  These presentations and sessions were concentrated around electronic submissions assembly, distribution and management.

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