Zamann supports pharmaceutical companies in developing comprehensive analytical strategies for nitrosamine and NDSRI control in accordance with ICH M7, EMA and FDA guidance. Our approach provides the framework, documentation and implementation strategy required to define analytical testing approaches, validation requirements and lifecycle management for regulatory compliance.
Developing a structured analytical strategy that defines when analytical testing is required, appropriate testing approaches, sampling strategies and decision-making criteria throughout the product lifecycle. The framework provides standardized documentation and guidance to support consistent analytical planning across all medicinal products.
Supporting the development of scientifically justified analytical strategies, including method selection, validation planning, sensitivity requirements, and regulatory expectations for nitrosamine and NDSRI analysis. Our framework assists clients in establishing robust analytical methods that meet current regulatory requirements.
Providing a structured strategy for analytical testing programmes, result management, trend evaluation and documentation throughout the product lifecycle. Zamann supports clients in planning routine monitoring, managing analytical data and maintaining inspection-ready documentation to support regulatory submissions and ongoing compliance.
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.
