Phoenix Pharma
LabWare
BA Unternehmensgruppe
Reckitt
BIONTECH
ratiopharm
SANOFI
Boehringer Ingelheim
Biotest
Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
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We offer a service to seamlessly integrate Nitrosamines ICH M7 adaption projects into existing Quality Management Systems (QMS), with minimal disruption to routine operations. By focusing on these aspects, our service goes beyond mere integration, offering a holistic approach to QMS alignment that drives continuous compliance and operational excellence.
Comprehensive review of QMS documentation, including SOPs, policies, and procedures, to identify areas requiring alignment with Nitrosamines requirements.
Assessment of existing risk management processes to ensure they encompass Nitrosamines-related risks and mitigation strategies.
Tailored development of integration milestones and deliverables, considering the specific requirements of Nitrosamines adaptation projects and the QMS.
Identification of key performance indicators (KPIs) and metrics to track progress and ensure successful integration within the established timelines.
Collaboration with cross-functional teams to gather insights and perspectives on the integration process, fostering a collaborative approach.
Provision of targeted training sessions on Nitrosamines regulations and their implications for different departments within the organization.
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.
