Global Regulatory, Quality, and Technology Services

For an industry that discovers, develops, produces, and markets drugs, pharmaceutical manufacturers must adhere to strict regulations for patient safety. For more than 20 years, USDM Life Sciences has been providing solutions that ensure continuous compliance and validation.  

Pharmaceutical companies operate in an industry known for long and costly R&D cycles, heavy regulatory scrutiny, and pressures to recoup investments before generics absorb market share. USDM’s pharmaceutical expertise streamlines processes and platforms while creating a simplified approach from the multitude of compliance requirements.

Areas of Expertise

 

Regulatory Product and Packaging Support

USDM will help you assess your products and the markets where they are sold. Our assessment methodology is extensive and includes:

  • Labels and packaging
  • Identifying product changes
  • Managing changes to PLM, ERP, EPCIS, and packaging systems
  • Changes to printing
  • Visual inspection
  • Warehouse and inventory management systems
  • Interfaces to foreign medical agency databases for pharmaceutical tracking

USDM ensures that all changes and enhancements are implemented under the governing GMP regulations and validated prior to production.


Additional Resources

Case study: Actionable Cybersecurity Roadmap for a Growing Pharma Company
Case study: Optimized Use of TraceLink Helps Pharma Company Implement Serialization
Blog: Benefits of Pharmaceutical Serialization

Areas of Focus
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Thought Leaders

Leading experts in every Life Sciences field

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Bob Lucchesi
Bob Lucchesi

Vice President of Global Regulatory Compliance, Quality Assurance and Auditing

Jay Crowley
Jay Crowley

Vice President of Medical Device Solutions and Services

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