Technology Transfer & Process Lifecycle

• Technology transfer planning and execution

• Process scale-up and manufacturing readiness demonstration through engineering runs

• Predictive scale-down model design and qualification, process characterization planning 

• Drafting of process validation master plans and protocols for individual studies (including PPQ)

• Data analysis and capture of process characterization and validation in individual study and master reports

• Planning and support for Continued/Ongoing Process Verification and technical Life Cycle Management 

Comparability Assessment

• Pre- and post-change product quality and regulatory impact assessment

• Comparability strategy design and protocol generation

• Support of comparability exercise execution

Investigations & Root Cause Analysis

• Manufacturing failure investigations and root cause analysis

• Deviation triage and quality impact assessment support

• Manufacturing and analytical data analysis and trending

• CAPA assignment, support of execution and effectiveness assessment

Change & Risk Management

• Quality and manufacturing impact assessments of complex changes 

• Pre- and post-change gap analysis

• Mitigation action planning and execution

• Oversight of change implementation

Batch Disposition Support

• Technical support for product batch disposition

• Deviation impact assessments and CAPA assignment

• Assessment of manufacturing events for potential product impact

• Technical input to QA disposition decisions

Outcome: Science-based, risk-managed solutions that protect product quality, maintain manufacturing continuity, and support compliant product release