Some of Our Services

Strategy alignment and culture change

Delivering Operational Excellence, using quality levers
Quality and Regulatory strategic leadership
Building a culture of personal ownership of quality
Aligning recognition and reward with culture
Balancing psychological safety and accountability
Building a quality strategy to align with company goals
Using quality as a source of competitive advantage
Available on a direct consulting or contract basis

Quality systems expertise

ISO 13485, ISO 9001,21 CFR 820, MDSAP, IVDR
21 CFR 210 & 211, EU GMP's
Audit response, remediation, and warning letter mitigation
CAPA effectiveness monitoring and metrics
Technical evidence generation and presentation

Technical domain expertise

Sterility assurance - Steam, Gamma, EO & aseptic processing
Microbiological methods
Clean room validation, operations and monitoring
Contamination control
Quality Control
cGMP manufacturing - large volume & small volume parenterals, medical devices, diagnostics and radiopharmaceuticals