Audit Services
(Program and site Level)

• 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

Procedural Document Systems (QMS)

• 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

Executive on Loan

• Strategic resource for high visibility    initiatives
• Management level SMEs with extensive    experience within drug development

Get in Touch

Reach out to our dedicated team for any inquiries, appointment scheduling, or support.

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