Enable Pharmaceutical and Biotech companies to take control of regulatory affairs and regulatory operations across their global enterprise, fostering compliance and improving regulatory submission efficiency.
Regulatory requirements can challenge the most dedicated and process-driven organizations. With numerous and frequently changing regulatory areas to focus on, the challenges grow when trying to manage and synchronize information and content from CRO’s, CMO’s and other partners. The challenge then 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.
Key Hightlights and Benefits
Single platform provides full traceability to R&D requirements
Shorten content review and approval cycles by up to 40%
Higher quality submissions with fewer iterations, enhancing chances for success
Reduces IT and system ownership costs with a flexible, out of the box system complete with a validation package to accelerate deployments
Compliance with global eCTD standards
Enables rapid adoption of new regulations or internal changes with flexible configuration capabilities
Validation-ready and designed for 21 CFR Part 11 and Annex 11 compliance
Enhances maturity of submissions and document lifecycle processes to mitigate the risk of future compliance mandates.
Accelerate time to market through improved regulatory submission assembly, review and approval processes