Pre-Commercial / Emerging

Regulatory Support for Pre-Commercial, Emerging Companies

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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:

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-sizephase appropriate, pragmatic quality management, and IT compliance programs.

We Help Start-Up and Emerging Life Science Companies:

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:

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.

Get in touch with our team to accelerate your digital transformation today.

USDM Thought Leaders