Quality Consultancy Services

Although we provide very specific consultancy services, our whole approach to the way that we engage, is objective and consultative. We have many examples to show that our method of objectively challenging a project in a consultative manner has led to some extremely beneficial and innovative outcomes for our clients.

Our specific Consultancy Services cover:

  • Regulatory Filings & QP services – preparation and submission of Manufacturing licence, IND, NDA, DMF & BLA.
  • Mock Inspections and Compliance Auditing – FDA (CDER, CBER & CUM), ISO 9001, 14001, OSH I8001, 20000 & 27001) EU GMP, UK MHRA and UK Home Office inspections.
  • Training – Development and delivery of in-house training programmes.
  • Compliance with Safety, Health, Environmental and Animal Welfare Regulations.
  • Operational Efficiency – GMP and Operational Excellence
  • Masterplanning
  • Validation – computer, equipment, process, cleaning