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Whitepapers & Publications
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Whitepapers
Preparing for Mandatory eCTD Submissions to FDA
41 Kb - PDF Biosimilars: Global Impact
181 Kb – PDF Pediatric Exclusivity and Drug Development Requirements in the Overall Pediatric Population
32 Kb – PDF The Regulatory Paradox of Laboratory Developed Tests
39 Kb – PDF Outsourcing: A Rapid, Cost-Effective Option for Electronic (eCTD) Submissions
47 Kb – PDF Preparing for Mandatory Electronic Submission of Drug Establishment Registration and Drug Listing Information
39 Kb – PDF The U.S. FDA Orphan Drug Product Program
36 Kb – PDF Evaluating the Electronic Submissions Challenge in the Pharma and Biotech Industries
36 Kb – PDF Risk Evaluation and Mitigation Strategies (REMS) under FDAAA
37 Kb – PDF
Publications
Meeting Report – DIA Conference on EDM and eCTD – February 2009
147 Kb – PDF Meeting Report – 7th Annual DIA Conference on eCTD – November 2008
145 Kb – PDF
Audio Conference Slides
Electronic Drug Establishment Registration and Drug Listings – October 2009
127 Kb – PDF Electronic (eCTD) Submission Myths – September 2009
471 Kb – PDF API Drug Development – August 2009
330 Kb – PDF Optimizing Your CMC Program – June 2009
324 Kb – PDF Lifecycle Management of the eCTD and NeeS in Europe – April 2009
878 Kb – PDF Electronic Submissions in Europe – eCTD and NeeS – January 2009
406 Kb – PDF
