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PharmExpert Consultant LLP
Industry

Research Institutes

GLP, GCP and data-integrity support for research institutes and non-clinical laboratories.

Research Institutes manufacturing environment

Overview

Research institutes and non-clinical laboratories generate data that underpins regulatory and development decisions, so study integrity and GLP compliance are paramount.

PharmExpert supports research organizations with GLP and GCP audits, data-integrity assessment and quality-system development that keep research reliable and inspection-ready.

Regulatory challenges

  • OECD GLP and study-integrity compliance
  • Data integrity in laboratory systems
  • Quality-assurance-unit effectiveness
  • Computerized-system control
  • Sponsor and monitoring-authority expectations

How we help

  • GLP and GCP audits
  • Data-integrity audits and remediation
  • Quality-system and SOP development
  • Computer system validation
  • Training and GxP awareness

Quality & compliance support for research institutes

Talk to an independent PharmExpert specialist about your GxP, regulatory or quality challenge. We respond within one business day.