Quality Consultancy
Our method of objectively challenging a project in a consultative manner has led to beneficial and innovative outcomes for our clients.
REGULATORY FILINGS & QP SERVICES
Preparation and submission of manufacturing licence, IND, NDA, DMF and BLA
MOCK INSPECTIONS, COMPLIANCE AUDITING & TRAINING
FDA (CDER, CBER & CUM), ISO 9001, 14001, OSH I8001, 20000 & 27001, EU GMP, UK MHRA, UK Home Office inspections
Development and delivery of in-house training programmes
COMPLIANCE
Safety, health, environmental, animal welfare
OPERATIONAL EFFICIENCY
GMP and Operational Excellence, Quality by Design, Environmental Control and Energy Saving
MASTER PLANNING
New facilities, renovations, expansion plans
VALIDATION
Computer, equipment, process, cleaning