OTTOBRUNN, GERMANY and MUNICH, GERMANY--(Marketwire - October 06, 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.
