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Biologics Consulting Group, Inc.
is pleased to make the following announcement:
Daniel Offringa joined Biologics Consulting Group, Inc as a Consultant in February 2005.
Mr. Offringa received a BS in Zoology from Duke University in 1989. From 1990-2001 he was a Biologist in the Division of Viral Products, Center for Biologics Evaluation and Research, FDA. He was responsible for the review of IND and BLA submissions, performing serologies used for Influenza vaccine strain selection, advisory committee presentations, supplying viruses to vaccine manufacturers, and testing and lot release of vaccine.
From 2001-Present, Mr. Offringa was an IT Specialist in the Office of Information Management, CBER. He served as technical lead for the CBER electronic submissions program and system administrator of the electronic document room and secure e-mail infrastructure. His duties included quality control and loading of eIND, eBLA and eCTD submissions, technical editing of electronic submissions guidance documents, reviewing and providing feedback regarding demonstration electronic submissions, assisting Industry with the establishment of secure e-mail communications with CBER, and recommending solutions to problems with electronic submissions.
As a Consultant at Biologics Consulting Group, Inc Mr. Offringa
will utilize his regulatory and electronic submissions expertise
to assist clients in the following areas:
- Preparation
and Quality control of eIND, eBLA and eCTD submissions
- Converting
source documents to PDF format
- Using
guidance compliant file naming conventions
- Generating
guidance compliant folder structures
- Adding
comprehensive hyperlinks to PDF documents
- Full
text indexing of PDF documents
- Generating
the XML backbone for eCTD submissions
- Implementation
of digital signatures
- Communication
with FDA via secure e-mail
- Representing
clients in interactions with the FDA
View Mr. Offringa's Curriculum Vitae...
Page Updated April 13, 2010