Our Approach
Regarding Audits, all of our auditors are IRCA trained to the highest standards.
Training is also a service we offer; we provide tailor-made training modules to suit your needs and fill the gaps.
Audits
in Pharma & Biotech
• GCP (Investigator sites, CROs… )
• GVP / PV (Partners, Affiliate, Systems)
• GLP & GCLP
• GMP (CMOs, sites)
• GDP
• Computer System Validation (CSV)
• Pre-Inspection Preparation (MHRA – FDA – EMA – ANVISA – ISO)
• QMS – ISO 9001
• Mock Inspections (FDA, EMA)
• Gap Analysis
• Remediation Activity Auditing
Audits
in MEDTECH
• QMS – IS0 13485
• EU MDR – Regulation (EU) 2017/745
• EU IVDR– Regulation (EU) 2017/746
• 510(k)
• 21 CFR 820
• ISO 14971
• ISO 62304
TRAINING in BIOTECH
& MEDTECH
• Good Manufacturing Practice (GMP)
• Quality Management System
• Good Distribution Practice (GDP)
• Good Clinical Practice (GCP)
• Responsible Persons Training
• Regulatory Compliance
• Technology Transfer
• Risk Management
• Six-Sigma
• Computer System Validation
• Validation training (Equipment, Process, Cleaning)
