Zamann develops standardized risk assessment frameworks that enable pharmaceutical companies to systematically evaluate nitrosamine and NDSRI risks throughout the medicinal product lifecycle. Our assessment methodologies are aligned with ICH M7, EMA, and FDA guidance and provide a structured approach for identifying, documenting, and scientifically justifying potential nitrosamine risks.
Our strategy consists of multiple interconnected risk assessments that evaluate every critical source of potential nitrosamine formation. Standardized templates guide users through the collection of relevant scientific information while ensuring consistency, traceability and regulatory compliance.
The framework includes:
Each assessment is designed to collect the information required to evaluate whether a potential nitrosamine or NDSRI risk exists. By combining data from raw materials, APIs, excipients, manufacturing processes, suppliers and scientific evidence, the framework enables a scientifically justified overall risk conclusion and supports consistent decision-making.
Standardized documentation templates ensure that all risk assessments follow a consistent methodology and capture the information expected by regulatory authorities. The framework supports transparent scientific justification, inspection-ready documentation and alignment with current ICH M7, EMA, and FDA expectations.
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.
