Health & Fitness
Health and Fitness
Health and Fitness
Fri, June 11, 2010
Thu, June 10, 2010 Celldex Therapeutics Selects EXTEDO eCTDmanager Suite to Manage Global Regulatory Submissions
WEST CHESTER, PA--(Marketwire - June 10, 2010) - [ EXTEDO ], a key eRegulatory Affairs solutions provider for life sciences firms, today announced that Celldex Therapeutics, Inc. (
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.
About EXTEDO
EXTEDO is the key solutions and services provider in the field of eRegulatory Affairs. The complete EXTEDOsuite is unique in all that it covers: Product Registration Planning & Tracking, Submission Management, Pharmacovigilance Management, Label Management, and Document Management.
EXTEDO provides configurable off-the-shelf products, as well as customized and integrated solutions. EXTEDO also provides EURS is Yours, the validation, review and approval system for the EMA and more than 25 Regulatory Authorities worldwide.
Today EXTEDO serves more than 700 customers in 57 countries ranging from small companies with less than 25 employees to large multi-national organizations. EXTEDO operates in the following markets for human, veterinary and crop protection: Life sciences, including pharmaceutical, biotech and biopharma, generics, homeopathics and medical devices, healthcare, and public sector. EXTEDO is recognized as the worldwide leader in each of its areas of operation.
For more information visit [ www.extedo.com ].
About Celldex Therapeutics, Inc.
Celldex Therapeutics is the first antibody-based combination immunotherapy company. Celldex has a pipeline of drug candidates in development for the treatment of cancer and other difficult-to-treat diseases based on its antibody focused Precision Targeted Immunotherapy Platform. The PTI Platform is a complementary portfolio of monoclonal antibodies, antibody-targeted vaccines and immunomodulators used in optimal combinations to create novel disease-specific drug candidates. For more information, please visit [ http://www.celldextherapeutics.com ].
All trade names, trademarks, and service marks are the rightful property of their respective owners.
