Celldex Selects EXTEDO eCTDmanager Suite to Manage Global Regulatory Submissions
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EXTEDO, a key eRegulatory Affairs solutions provider for life sciences firms, has announced that Celldex Therapeutics, Inc., an antibody-based combination immunotherapy company based in Needham, Massachusetts, has selected the eCTDmanager Suite™ to manage regulatory submissions across the company.
The EXTEDO eCTDmanager Suite provides Celldex Therapeutics with an easy-to-use electronic management solution for building, viewing, validating, and publishing compliant submissions that meet global regulatory specifications.
Celldex Therapeutics will also be using DOCvalidator™ and GECCO™ from EXTEDO to verify that all regulatory documents are properly formatted and compliant before being filed electronically.
“We did extensive research on all of the submission management solutions that are currently available,” stated Audrey Louie, Ph.D. and Director of Regulatory Affairs at Celldex Therapeutics. “The EXTEDO solution offered the broadest set of off-the-shelf capabilities at the best value.”
“It is no secret that regulatory agencies around the world want life sciences firms to file their submissions electronically,” stated Tore Bergsteiner, CEO for EXTEDO. “We have deployed our solutions at small biotechs, as well as large pharmaceutical companies, which enables us to help any size firm move to electronic submissions.”
EXTEDO life sciences industry experts will be demonstrating eCTDmanager, PcVmanager, DOCvalidator, and GECCO in booth 2000 at the 46th DIA Annual Meeting, in Washington D.C., on June 14-16, 2010.
The EXTEDO eCTDmanager Suite provides Celldex Therapeutics with an easy-to-use electronic management solution for building, viewing, validating, and publishing compliant submissions that meet global regulatory specifications.
Celldex Therapeutics will also be using DOCvalidator™ and GECCO™ from EXTEDO to verify that all regulatory documents are properly formatted and compliant before being filed electronically.
“We did extensive research on all of the submission management solutions that are currently available,” stated Audrey Louie, Ph.D. and Director of Regulatory Affairs at Celldex Therapeutics. “The EXTEDO solution offered the broadest set of off-the-shelf capabilities at the best value.”
“It is no secret that regulatory agencies around the world want life sciences firms to file their submissions electronically,” stated Tore Bergsteiner, CEO for EXTEDO. “We have deployed our solutions at small biotechs, as well as large pharmaceutical companies, which enables us to help any size firm move to electronic submissions.”
EXTEDO life sciences industry experts will be demonstrating eCTDmanager, PcVmanager, DOCvalidator, and GECCO in booth 2000 at the 46th DIA Annual Meeting, in Washington D.C., on June 14-16, 2010.
