GCP services tailored to the needs, size, and resources of your company

The USDM Life Sciences Clinical Practice institutes a proactive approach to compliance and quality assurance that fosters continuous process improvement to provide the most efficient process for drug development and submission activities.   Identify compliance issues that are relevant to your organization, assess compliance issue significant and relationship to other potential concerns, develop and strategic compliance management plan and ensure compliance implementation.

Regulatory approval processes are complex to navigate and can often cause costly delays. Our Clinical experts can help you gain a solid understanding of global regulations to ensure all clinical activities are in compliance. Having worked with companies of all sizes in all regulated fields (including clinical trials, medical devices, and biological products), USDM is equipped to assist in every aspect of internal GCP auditing, analysis, corrective actions, process development and training.

Services:

  • GCP Assessments
  • Good Clinical Practice (GCP) Auditing
  • Gap Analysis/CAPA
  • Risk Assessment
  • Vendor Selection/Auditing/Oversight
  • Inspection Readiness
  • Drug Accountability Auditing
  • SOP Development
  • Training

Thought Leaders

Leading experts in every Life Sciences field.

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Bob Lucchesi

Vice President of Global Regulatory Compliance, Quality Assurance and Auditing

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