top of page

Nitrosamine Evaluation & Remediation

Stay on top of evolving nitrosamine concerns with Mindful Quality. From assessment to remediation our experts have you covered.

Mindful Quality’s team guides clients through the rapidly changing nitrosamine regulatory expectations. This process can include writing and evaluating risk assessments, analytical methods, remediation, and third-party nitrosamine de-risking reports to mitigate nitrosamine impurity concerns.

Risk Assessments

Mindful Quality experts can help you with your contamination control strategy (CCS). Trust the team that's experienced with conducting and reviewing risk assessments related to nitrosamine contamination or formation in APIs and drug products.

Detection and Remediation

Mindful Quality can assist with all your nitrosamine detection and remediation efforts. Developing and validating analytical methods that are sensitive enough to detect the presence of nitrosamines. Help establishing acceptable cleaning limits for nitrosamine contaminants.

De-Risking Reports

Mindful Quality can evaluate your cleaning program and the activities you have performed to reduce your nitrosamine risk profile. After reviewing all these activities, our experts will write a third-party nitrosamine de-risking report that documents all your remediation efforts and can be submitted to health agencies.

How Can We Help?

Tell us what you're looking to achieve.  We'll put our experience to work to solve your specific problem.  If you have any questions or inquiries, please do not hesitate to contact us. Our team is here to assist you and provide you with the information you need.

bottom of page