Good Clinical Practice (GCP) Compliance and Quality Assurance

Our Good Clinical Practice (GCP) Compliance and Quality Assurance subject matter experts help our clients gain a solid understanding of global regulations and offer guidance, solutions and services that ensure all clinical activities are completely in compliance with government regulations. Regulatory approval processes are complex to navigate and can cause costly delays. 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.

The USDM Life Sciences Clinical Practice offers compliance and quality assurance experts who identify compliance issues that are relevant to your organization, assess compliance issue significance and relationship to other potential concerns, develop a strategic compliance management plan and ensure compliance implementation. Our services are tailored to the needs, size and resources of your company.

Regulatory agencies are consistently increasing their number of inspections. Audit plans are needed to document the oversight of clinical trials and make sure your company is ready for an audit at all times. Our audit team has worked with companies of all sizes in all regulated fields, including clinical trials, medical devices and biological products.

The USDM Life Sciences Clinical Practice assists our clients with every aspect of internal GCP auditing, analysis, corrective actions, process development and training to ensure full compliance and the highest quality. We extend the same complete process in vendor and investigator/site auditing services to provide our clients the opportunity to discover and remedy all GCP compliance findings prior to or during vendor engagements.

GCP audits can both show a proactive approach to submission readiness and are key in the documentation of clinical process oversight, maintenance and diligence. Our audit team has worked with companies of all sizes to conduct pharmaceutical, biologic and medical device clinical trials.

GCP Compliance and Quality Assurance Services:

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