A Complete Web-based EDMS Solution for Biotechnology
Companies Preparing for Regulatory Submission that is
Delivered Pre-configured and Ready to Use.

Are you a biotechnology company -

In need of control over your documentation?
In early clinical trials?
Planning an upcoming submission, or plan to make a submission after January 2010?
Planning to submit in the EU (eCTD deadline January 2010)?

The QUMAS Biotechnology Package is an affordable package that has been created specifically for small biotechnology companies, in order to give them access to QUMAS DocCompliance, the leading electronic document management system used by tier one and tier two companies globally. Growing biotechs can now afford world class document control, preconfigured with industry practices, and validated and live within 30 days. These companies can also leverage the QUMAS expertise, as configured in the system, to ensure that they operate a compliant organization from the outset, making them more viable in a regulatory context and more attractive to investors and partners.

A Cost Effective EDMS

Low upfront cost, with a rental model of €1 a day per user
A pre-configured, validated solution that dramatically reduces the cost of regulatory compliance for biotechnology companies
No expensive consulting required to customize the system
Pre-packaged IQ/OQ/PQ documents automate and accelerate the validation process, reducing cost and stress

About QUMAS: QUMAS is the leader in Regulatory Compliance Solutions with more than 250 global customer deployments and over 15 years of experience helping companies in highly regulated industries.