Pre-Commercial / Emerging
Regulatory Support for Pre-Commercial, Emerging Companies
USDM helped a pre-commercial company to enhance and harmonize, its QMS to prepare for an upcoming pre-approval inspection and meet its regulatory compliance objectives.
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.
GxP Collaboration for Emerging Companies
Pre-commercial startups are faced with so many competing demands and priorities and have very unique needs. Often these rapidly growing companies lack the resources or GxP expertise to move full speed ahead. USDM has helped hundreds of emerging companies with understanding global regulations and executing a technology strategy to chart a path to success.
Additionally, USDM can provide related services such as:
- Auditing, both external (vendor) and internal
- Vendor/Product selection assistance
- Data Migration
- Staffing Services
- Training Services
- Organizational Change Management
through commercialization. See a preview of the discussion below.
To watch the full-length on-demand webinar, click here.
Have a question about how we can work with your specific GxP system setup?
Fill out our contact form with your system requirements and we can review them.