SOURCE: EXTEDO

August 25, 2010 08:00 ET

Submission Consulting Group Standardizes on EXTEDO eCTDmanager Suite for Global Regulatory Submissions

MUNICH, GERMANY and OTTOBRUNN, GERMANY--(Marketwire - August 25, 2010) -  EXTEDO, a key eRegulatory Affairs solutions provider for life sciences firms, today announced that Submission Consulting Group, a life sciences consulting firm, has selected the eCTDmanager Suite™ to manage regulatory submissions for its growing roster of clients.

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

"We don't have an internal IT staff, so we needed a cost effective and easy-to-install and maintain submission management solution," stated Jeff Wilson, Principal Consultant at Submission Consulting Group. "The solution also needed to handle all types of submission formats -- paper, hybrid and electronic -- since we prepare filings on behalf of our clients for various agencies around the world. I have used a number of submission management solutions in the past and the only one that was able to meet all of our requirements was the eCTDmanager Suite from EXTEDO."

"Making sure that our products are easy-to-use and easy-to-maintain are top priorities for us," stated Oliver Bojahr, Vice President of Global Products for EXTEDO. "The installation process for the eCTDmanager Suite is straightforward, and the user interface is very intuitive so firms can be up and running in a few hours."

EXTEDO life sciences industry experts will be demonstrating PcVmanager at the World Drug Safety Congress, September 15-16, 2010 in London and the EXTEDOsuite including eCTDmanager at the 7th Annual TOPRA Symposium, October 4-6, 2010 in London.

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, Labeling 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 Submission Consulting Group

Submission Consulting Group's team of professionals provides a comprehensive set of document management and regulatory publishing services to the life sciences industry. SCG's primary focus is assisting pharmaceutical and biotech companies in completing agency submissions in addition to regulated publishing and documentation management system validation, integration, and implementation activities. Competent in providing expertise in the selection and implementation of regulated publishing and documentation management products and services geared toward the final submission milestone.

SCG provides submission creation, management and filing services in a variety of paper and electronic formats for health authorities in the US, Canada, EU and rest of world. SCG can perform business readiness assessment, submission readiness assessment, requirements analysis, project planning, implementation, validation, submission publishing and assembly and application submittal.

SCG's virtual publishing system (VPS) can be operated from their offices in San Diego and San Francisco or set-up at the sponsor's location. By working from the sponsor's location document and data security is assured.

For additional information: info@submissionconsulting.com

All trade names, trademarks, and service marks are the rightful property of their respective owners.

Contact Information

  • Media Contact:
    Michael Kane
    EXTEDO
    Tel: +1-978-257-2179
    Email: Email Contact