Quality Consultancy

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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