EXTEDO eCTDmanager Suite Enables Pharmaceutical Holding FIS SA to Submit New Product Dossiers Electronically to Multiple Regulatory Agencies Throughout the World
EXTEDO Solution Sold and Supported by KLever
Ottobrunn/Munich, Germany – September 08, 2009 – EXTEDO, a key eSubmission solutions provider for life sciences firms, today announced that Pharmaceutical Holdings FIS (PHF) SA, based in Switzerland, is using the eCTDmanager Suite™ to manage regulatory submissions for new products across the company. KLever, a life sciences consulting firm based in Italy, sold the EXTEDO solution to PHF SA and provides ongoing support.
The EXTEDO eCTDmanager Suite provides PHF SA with an easy-to-use electronic management solution for building, viewing, validating, and publishing compliant submissions that meet global regulatory specifications.
“After working with KLever and using the EXTEDO solution since last July we are absolutely convinced that we have the right solution and support for our company,” stated Laura Castagno, Quality Assurance & Regulatory Affairs Manager at PHF SA. “Since the EXTEDO solution is easy to use the training process went smoothly and we were working on compiling dossiers almost immediately after the installation. Additionally the solution is very adaptable, even for nutritional needs, another area we are quite active in.”
“Since 2006 a number of European regulators have been convincing life sciences firms to embrace the eCTD format for electronic submissions,” said Tore Bergsteiner, Managing Director for EXTEDO. PHF SA being one of the first European companies in the chemical-pharmaceutical sector to adopt the eCTD format is a step ahead of its competitors.
About KLever
KLever is the only Italian IT company with the experiences and competencies to implement Document Management Systems and eSubmission/eCTD solutions in a critical environment.
The team of professionals in the KLever Life Science Practice understands the challenges facing Life Sciences firms today and has experience providing a wide range of technology solutions.
For more information visit www.k-lever.it.
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.
Press Release