Quality Assurance

AlcheraBio’s Quality Assurance (QA) unit is headed by Nicholas Meo, AlcheraBio senior clinical research coordinator. Mr. Meo has more than 30 years of experience in the human and animal health industries, including R&D, clinical research, QA and regulatory affairs. He has coordinated laboratory and clinical studies, monitored clinical and non-clinical studies (GLP and GCP), and served as a study director for GLP worker exposure studies. He has established QA systems and developed and administered SOPs. Mr. Meo’s work is known throughout the animal health industry.

Mary Margiasso-Cafferty, an AlcheraBio clinical research coordinator, also has QA-related responsibilities.

AlcheraBio offers QA services to support GCP and GLP.

GCP Quality Assurance
• Development of QA programs for clinical studies
• Training of clinic staff and QA Auditors in VICH GL9 GCPs
• Training of clinic staff in handling FDA inspections
• On-site audits of procedures, records, and data
• Audits of databases and draft and final reports

GLP Quality Assurance
• Development of QA programs for new facilities
• Training of staff and QA Auditors in GLPs and handling FDA inspections
• Facility inspections
• On-site in-life audits
• Audits of raw data, databases, draft, and final reports