Fast Track from R&D to Commercialization
Rapidly growing pre-commercial or newly commercialized biotechs, pharmaceutical, medical cannabis, and medical device companies with innovative technologies are undergoing massive process, technical, and cultural changes.
USDM Life Sciences’ Emerging team helps hundreds of pre-commercial life science customers reach commercialization faster or manage steady-state compliance and IT outsourcing for companies who are downsizing to restructure their pipeline.
We are experts at developing right-size, phase appropriate, pragmatic quality, and IT compliance programs. Our Emerging team assists and guides start-up companies in:
- Regulatory compliance
- Quality validation and testing
- Program management
- Training and communications support for dozens of quality, content, lab, ERP, and clinical cloud systems.
Commercialization Action Plans for Life Science Start-Ups
We also have expertise in helping start-up life science companies to:
- Significantly reduce implementation and validation time while decreasing the cost to manage cloud compliance by leveraging pre-packaged solutions
- Maintain continuous cloud compliance with our Cloud Assurance managed services for change management and audit reports for many GxP cloud application releases, for systems such as: Veeva, DocuSign, Box, Oracle, SharePoint, ComplianceWire, and many more
- Drive the ROI of IT investments by increasing end-user adoption with USDM’s Organizational Change Management methodology for GxP application training and communications
- Stay FDA & EMA compliant through your process to commercialization
We help start-up and emerging life science companies:
- Accelerate Technology Roadmaps
- Accelerate Process Maturity
- Accelerate Regulatory Readiness
- Accelerate Service Delivery
From Paper to GxP Digital Platform
Rapid Deployment of Enterprise-Wide GxP Applications
CSV Program and Application Validation in Less than 6 Weeks