Nitrosamines risk & control strategy
Nitrosamines risk assessment remains a top regulatory priority for APIs and finished products. Global authorities require in-depth nitrosamines risk evaluation.,. Our nitrosamines consulting services provide full-service regulatory strategy, from risk identification to confirmatory testing support and regulatory updates.
We help you proactively manage nitrosamine formation risks and maintain compliance with evolving EMA and FDA guidance.
Nitrosamines risk assessment across APIs, excipients, Packaging and manufacturing process.
Acceptable Intake Calculation
Calculation of nitrosamine acceptable intake (AI) limits in alignment with EMA and FDA regulatory guidance. Read-across analysis for AI prediction.
Acceptable intake calculation
Calculation of nitrosamine acceptable intake (AI) limits in alignment with EMA and FDA regulatory guidance.
Mitigation & control strategy
Development of nitrosamine mitigation strategies including process controls, raw material review, and supplier qualification.
Confirmatory testing support
Strategic consulting for confirmatory nitrosamine testing and regulatory reporting.
Regulatory monitoring and lifecycle updates
Ongoing nitrosamines regulatory monitoring and lifecycle management support.