Regulatory Support for Pre-Commercial, Emerging Companies

Fast-track your journey from R&D to commercialization.

In a complex, competitive, and fast-paced market, startups in biotechnology and pharmaceuticals face many challenges. USDM’s experienced professionals can help you navigate the regulatory landscape and achieve compliance.

Let’s plan your roadmap for success.

Preparing for Commercialization

Creating a plan for your organization’s research and development, operational standards, pricing and marketing, and vendor selection (and more!) can be difficult if you are a new or emerging company.

USDM has decades of experience helping startup life sciences companies to:

• Reduce implementation and validation time
• Decrease 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
• Implement a Commercialization QMS Framework Drive the ROI of IT investments and increase end-user adoption with USDM’s Organizational Change Management methodology for GxP application training and communications​

USDM’s Commercialization QMS Framework

The USDM Commercialization QMS Framework is a top-down solution designed to reinforce your quality goals and objectives, and implement a governance structure that supports your operations and procedures and organizational roles and responsibilities.

This framework provides a strategic and comprehensive compliance roadmap and ensures that its implementation complements your existing QMS program and fills any gaps.

Our Commercialization QMS Framework complies with:

• U.S. Food and Drug Administration (FDA) cGMP regulations 
• European Medicines Agency (EMA) regulations
• Health Canada requirements
• Japan’s Pharmaceuticals and Medical Devices Agency regulations
• The United Kingdom’s Medicines and Healthcare Products Regulatory Agency regulations
• And many other global regulatory authorities

We’re ready to work with your Quality Assurance and Regulatory Affairs teams and meet your goals for quality and compliance.  We are experts at developing right-size, phase appropriate, pragmatic quality management, and IT compliance programs.

We Help Start-Up and Emerging Life Science Companies:

• Accelerate Technology Roadmaps
• Accelerate Process Maturity
• ​Accelerate Regulatory Readiness
• ​Accelerate Service Delivery
• Accelerate Quality Management Program Implementations
• Accelerate implementations of Computer System Validation and Computer Software Assurance Programs

Contact us to learn more or read on to see our work in action.