March 30, 2010 08:00 ET

Avrio Biopharmaceuticals Selects EXTEDO eCTDmanager Suite to Manage Regulatory Submissions Worldwide

WEST CHESTER, PA--(Marketwire - March 30, 2010) -  EXTEDO, a key eSubmission solutions provider for life sciences firms, today announced that Avrio Biopharmaceuticals, LLC, a premier contract development and manufacturing organization based in Irvine, California, has selected the eCTDmanager Suite™ to manage regulatory submissions across the company.

The EXTEDO eCTDmanager Suite provides Avrio Biopharmaceuticals with an easy-to-use electronic management solution for building, viewing, validating, and publishing compliant submissions that meet global regulatory specifications.

"The United States, Europe, and China are important markets for our company," stated Yasamin Ameri, RA and QA Director at Avrio Biopharmaceuticals. "With a single solution from EXTEDO we are able to handle the submission requirements for these countries and are also prepared to meet the requirements of any other global agency."

"Avrio Biopharmaceuticals chose the EXTEDO solution after an extensive evaluation that included in-house demos from six different vendors," said Harv Martens, Vice President for North America and Japan at EXTEDO. "Key factors influencing the decision to select EXTEDO were how easy our solution was to use, extended support, and our long history in the regulatory submissions field."

About Avrio Biopharmaceuticals, LLC

Avrio Biopharma, an affiliate of Irvine Pharmaceutical Services, is a premier contract development and manufacturing organization providing support to the pharmaceutical, biopharmaceutical, and medical device industries. Avrio, along with its Irvine affiliate, offers full cGMP product development support, specializing in preformulation/formulation, analytical development, process validation, scale-up studies, packaging and labeling, stability storage and complete analytical CMC testing. Learn more at or call 866-98-AVRIO (866-982-8746).


For nearly 15 years EXTEDO has been a key services and solutions provider in the field of regulatory data and document management (CTD, eCTD and other formats) for Life Sciences industries and authorities (Pharmaceutical, Crop Science, Chemicals). Based on well-founded expertise and many years of experience, EXTEDO provides highly standardized as well as customized solutions in the area of electronic Regulatory Affairs.

EXTEDO, being globally represented, serves more than 700 Life Sciences organizations in 57 countries.

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