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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