Quality assurance

We are able to provide you with a full range of independent GxP quality assurance auditing, consulting and training for pharmaceutical, biotechnology and medical device products according to client needs.

Quality assurance services

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Our global force ensures that there are enough staff members to guarantee client auditing and that consulting needs are scheduled, conducted, and reported on time. Our leadership and project managers make sure deliverables are on time and of the highest quality, allowing clients to manage and control their schedules.

With the help of our in-house knowledge and partners, we offer high quality service and expertise from:

GCP Audits

  • CRO/SMO Vendors
  • Internal Systems (Clinical operations, DM, MW)
  • Phase II to IV clinical study
  • Safety Systems & Vendors
  • Document audits: protocols, ICF, IB, CRF, CSRs, submissions
  • Clinical Database audits
  • Data Management & Biostatistics audits
  • IWRS audit
  • Clinical trial supply service providers
  • Trial master files (TMF)
  • For-Cause (Fraud, Misconduct)
  • Post-Marketing Safety
  • Internal Full PV & Drug Safety Systems
  • Vendors
  • Marketing & License Partners
  • Product Distributors & Warehousing
  • Document audits: PV Master files, PSURs, DSURs, Contracts & SDEA, RMPs
  • CS validation by internal IT specialist
  • Product Distributors audits
  • Product Warehouse audits
  • MAHs audits
  • Pre-Inspection Training
  • Inspection Hosting – Consultancy
  • Inspection Results Mitigation
  • Risk Assessment (system wide) and mitigation
  • GAP Analyses & SOP Development
  • GxP Training
  • Quality Management Evaluation
  • Temporary On-Site Auditor Placement
  • Auditor Training

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