Getting your process there faster and in compliance.

Our Toolkit

  1. Operational Excellence
    Quality by Design (QbD) Process Mapping On-floor Monitoring of Production Process Key Performance Indicators (KPI) Risk Management Project Management Change Management
  2. Technical Expertise
    Process Optimization & Characterization Process Scale-Up Technology Transfer Validation Data Evaluation Control Chart Trending
  3. Compliance Mindset
    Standardized Operating Procedures Batch Production Records Trouble-shooting & Investigation Root Cause Analysis Corrective & Preventative Action (CAPA) Discussions with Regulatory Agencies