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RISK ASSESSMENT AND REGULATORY COMPLIANCE

SERVICES

Your challenge is to handle an ever changing regulatory environment. The US-FDA, the EMA and many other global competent regulatory authorities publish new guidances and expect you to comply. You need a regulatory expert to help you stay tuned.

Our compliance services are tailored to your needs:

Performing Risk Assessment (RA) as part of your project team
Performing impact assessment as part of the lifecycle approach to validation
Conducting independent aseptic process compliance reviews
Training your staff in understanding/interpreting current regulatory guidance
Managing compliance projects at your facilities