Pharmaceuticals, Medical Device, and
Biotechnology Industry Experience

• Program & Project Management

• Computer System Validation (CSV)

• Commissioning, Qualification and Process Validation

• 21 CFR Part 11 Validation

• QSR, GxP, ICH, EMEA, MDD, ISO, GAMP 5 and other regulatory compliance standards

• Business Process Re-engineering (BPR)

• Facility Commissioning and Qualification

• Document Control and Knowledge Management

• Custom Software, Database Design, Development, and Documentation