Qualification & Validation

Design Protocols, oversee method
qualification / validation studies
Specification Setting

Identify product Critical Quality
Attributes
Method Development

Identify & select appropriate analytical
methods
Interim Functional Leadership

We can provide expertise & leadership
while you develop your team
Troubleshooting

Methods to remediate process &
test failures
Comparability Studies

Streamline future regulatory needs with
a bespoke roadmap
Product and process development planning

Development of comprehensive
process & product roadmap
Process Codification

Process Definition to meet regulatory
requirements
Process Evaluation

Clarify process performance & trends
Cleanroom Validation & Maintenance

Assess overall compliance level of a
classified cleanroom. Develop
Cleanroom Qualification, Maintenance
and Environmental Monitoring Program