Consulting

Compliance Services

• Audit Services
• Compliance Assessment and Gap Analysis
• Corrective Action and Preventive Action (CAPA) System
• Mock Inspections and Pre-Inspection Reviews
• Document development (SOP’s, Forms, Log Books, …)
• Regulatory Inspection Assistance
• GLP Consulting and Training
• 21 CFR Part 11 Compliance
• GAMP5 Training
• Computer System Validation

Facility Preparation

• Turn Key Services.
• Facility Design.
• Design Qualification.
• System Development.
• Recruitment and Training.
• Products & Services Evaluation and Procurement.