Bioforum Provides a wide range of regulatory
services throughout the product development and commercialization. We
believe in listening to our customers and adjusting our service offering
based on their skills and true needs – from regulatory strategy
consultation, through technical documents preparation to regulatory
dossiers compilation and submission in the European Union and/or in
North America.
Experts in Regulatory and Submission Management
Our regulatory team will work together with you
to identify the best pathway to get your product to market. Our solution
combines leading regulatory experts with best-of-breed publishing
platform. Key value-add areas include -
- Prepare, publish and compile paper and electronic submissions to national agencies around the world
- Submissions Lifecycle Management
- Agency communication management
- Regulatory Affairs consultation and gap analysis
As part of regulatory submissions, companies are required to follow
CDISC (Clinical Data Interchange Standards Consortium) standards for
their clinical data. Life science companies are rapidly adapting to
these standards and are facing conversion challenges with their legacy
studies as well as internal data management challenges with their
ongoing studies given the new standards. Bioforum is a CDISC Registered Solution provider
and has published CDISC Best Practices and Implementation Guides which
are used by global drug companies and service providers around the
world.
For more information please contact Eyal Wultz
Email: eyal.wultz@bioforum.co.il
Phone:+972-8-9313090