Zamann Pharma Support provides expert consulting services to support pharmaceutical companies in developing a robust risk management strategy for NDSRI (New Drug Substance-Related Impurities). Our goal is to help clients proactively manage and mitigate nitrosamine-related risks within new drug substances by designing custom frameworks aligned with ICH M7 and FDA expectations. This includes the development of internal procedures, documentation packages, and technical justifications tailored to the nature of NDSRIs. Our service ensures that clients are prepared for regulatory review, inspection readiness, and scientific evaluation of impurities within complex pharmaceutical substances from development to commercialization.
We assist clients in creating tailored risk assessment frameworks to evaluate NDSRI risks. This includes defining clear methodologies and scientific criteria that apply specifically to new drug substance reference standards. The framework includes hazard identification, prediction of impurity formation pathways, evaluation of structural alerts, and potential reaction mechanisms during synthesis. Each assessment tool is adapted to suit unique compound characteristics. Our goal is to enable systematic and consistent risk evaluation, enabling the identification and prioritization of NDSRI risks across development batches, process changes, or formulation adjustments—supporting both initial registration and post-approval lifecycle management.
In partnership with our clients, we develop practical mitigation strategies tailored to control NDSRI risks throughout the pharmaceutical lifecycle. These include implementing manufacturing adjustments, raw material controls, equipment cleaning procedures, and validated analytical techniques to monitor for nitrosamine formation. Our team guides the implementation of preventive and corrective actions, considering each product’s specific synthetic route and degradation profile. The strategies are embedded into SOPs and quality system controls to ensure traceability and repeatability. This approach not only reduces the potential for NDSRI occurrence but also strengthens overall GMP compliance and audit preparedness.
We conduct a detailed GAP analysis to evaluate existing NDSRI-related risk management activities. This includes a review of current SOPs, risk registers, impurity justifications, and control strategies to assess alignment with ICH M7 and FDA requirements. Our structured methodology helps uncover procedural gaps, missing risk evaluations, or outdated mitigation measures that may compromise regulatory compliance. Once identified, we provide actionable recommendations to correct deficiencies and elevate the existing control framework. This ensures companies are well-prepared for regulatory submissions, inspections, and long-term risk management of nitrosamine-related impurities in NDSRIs.
Our strategic approach to ensure Nitrosamine compliance is based on global and holistic experience, and can be perfectly adapted to your reality. We address the latest regulations and risk assessments, helping you manage and mitigate potential risks specific to your products and processes.
Zamann stays ahead of the evolving Nitrosamine requirements, providing expert guidance to ensure compliance with confidence. Our proactive and senior approach helps protect product integrity and patient safety, securing your operations against regulatory risks.
