License for Regulatory

Enable Pharmaceutical and Biotech companies to take control of regulatory affairs and regulatory operations across the global enterprise, fostering compliance and improving regulatory submission efficiency.

Regulatory requirements can challenge the most dedicated and process-driven organizations. This becomes trying to manage and synchronize information and content from CRO’s, CMO’s and other partners. The key becomes how to effectively manage the changes, and the flow of material from various partners and sites. Without effective management, regulatory hurdles can quickly clog the new product pipeline.

License for Regulatory enables life science companies to take control of quality and regulatory operations across their global enterprise, fostering compliance and improving operational performance. Designed for the highly-regulated life sciences industry, License for Regulatory provides end-to-end document and workflow management in alignment with regulatory guidances to reduce costs, improve efficiencies and accelerate submission of marketing applications to the appropriate regulatory bodies through improved regulatory submission assembly, review and approval processes.

License for Regulatory shortens content review and approval cycles by up to 40% by enabling higher quality submissions with less iteration, thereby improving successful submission creation and maintenance. And with a flexible, out of the box system complete with validation test scripts to accelerate deployments, biotech and pharmaceutical companies will see reduced IT costs that match their needs for fixed costs solutions and pre-defined configurations.