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• Internal and External Audits (e.g., Data Integrity assessments, GxP facility audits including central labs, IRBs, CROs, computer validation, software vendors, hosted services, etc.)
• Sponsor audit program establishment and improvement consulting
• Training and process development support
• Cyber and Data Privacy assessments
• CAPA and Deviation Management
• GxP Procedural system establishment or improvement (e.g., globalization, FA harmonization, regional/local alignment, etc.)
• EDMS system set-up and utilization consulting
• Process development facilitation
• Strategic resource for high visibility initiatives
• Management level SMEs with extensive experience within drug development
Reach out to our dedicated team for any inquiries, appointment scheduling, or support.
