SOURCE: EXTEDO

October 06, 2009 08:00 ET

Regulatory Pharma Net Relies on EXTEDO eCTDmanager Suite to Expedite Submissions for Life Sciences Clients

OTTOBRUNN, GERMANY and MUNICH, GERMANY--(Marketwire - October 6, 2009) - EXTEDO, a key eSubmission solutions provider for life sciences firms, today announced that Regulatory Pharma Net has selected the eCTDmanager Suite™ to manage their high volume of submissions for multiple life sciences clients throughout Europe.

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

Regulatory Pharma Net, with offices in Spain and Italy, has a team of over 40 professionals who assist European Pharmaceutical companies and biotechnology firms file submissions to authorities around the globe. "The number of electronic submissions that we have filed since purchasing the software in April of 2008 has grown steadily," stated Michael Schaub, Director of Business Development at Regulatory Pharma Net, S.L. "We have already sent out more than 200 electronic submissions to agencies within Europe, and we have recently became a validated eCTD provider to the FDA."

"Throughout Europe more and more countries require that life sciences firms file their submissions electronically to their regulators," said Andreas Suchanek, Managing Director for EXTEDO. "Regulatory Pharma Net can not only take care of the filings for companies, but also offers a wide range of consulting and support services, including seminars on European and FDA submission requirements and guidance on eCTD best practices."

About Regulatory Pharma Net

Our mission is to become the partner of choice for all stages of drug development and drug registration procedures.

Regulatory Pharma Net has more than 10 years of expertise being a reference Consultancy Company for International Regulatory Affairs worldwide.

Our experienced team of experts has a thorough understanding of R&D management and can help identify the correct strategy for successful drug registrations.

Key services involve regulatory strategy from the beginning of drug development, including support in all steps of R&D for new molecules. Latest activities in the regulatory field include the emerging of Advanced Therapy products and Pediatric Investigation Plans, which have quickly become an important field of activity in Regulatory Pharma Net.

"Our team involvement in our clients' projects is leading us to participate more and more in EMEA / PDCO / CAT and National Authorities Scientific Advice meetings. This experience, together with the R&D background of our team members, is a key factor," said David Mauleón, CEO for Regulatory Pharma Net, S.L.

"We consider each project as if the product was our own discovery, and the same does any team member," said Consol Bozzo, Senior Director at Regulatory Pharma Net, S.L. "We always consider strategies beyond the point where we are to achieve the maximum benefit for our client. This is our guarantee for success. Nowadays, eCTD is present in almost all projects and we are proud to offer high quality service."

For more information visit http://www.regulatorypharmanet.com.

About EXTEDO

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 600 Life Sciences organizations in more than 50 countries.

For more information visit www.extedo.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