Phoenix Pharma
LabWare
BA Unternehmensgruppe
Reckitt
BIONTECH
ratiopharm
SANOFI
Boehringer Ingelheim
Biotest
Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
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Services created to develop comprehensive Risk Assessments within Nitrosamines ICH M7 adaptation projects. We specialize in identifying and evaluating potential risks associated with nitrosamine impurities in pharmaceutical products, adhering to ICH M7 guidelines.
We gather detailed information on the manufacturing process, including raw materials, intermediates, and final products, to identify potential sources of nitrosamine formation.
We review historical data, analytical results, and relevant literature to assess the presence and levels of nitrosamines in pharmaceutical products.
Our experts assess the genotoxicity and carcinogenicity of nitrosamine impurities based on available toxicological data and regulatory guidelines.
We characterize the potential risks associated with nitrosamine exposure, considering factors such as dose, duration, and route of administration.
Using scientific principles and risk assessment tools, we evaluate the likelihood and severity of nitrosamine contamination in pharmaceutical products.
We prioritize risks based on their potential impact on patient safety and regulatory compliance, guiding the development of targeted risk mitigation strategies.
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.
