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Zamann Pharma Support provide service dedicated to develop robust Data Management strategies customized to meet ICH M7 and FDA requirements. We provide essential background documentation, including SOPs and internal guidelines, to enable clients to effectively manage data related to nitrosamine analysis and control.
Crafting detailed SOPs outlining procedures for data collection, storage, analysis, and reporting in accordance with regulatory guidelines.
Customizing SOPs to align with the specific needs and processes of the client’s organization, ensuring clarity and compliance.
Designing a comprehensive data governance framework to define roles, responsibilities, and processes for managing nitrosamine-related data.
Implementing protocols for data quality assurance, validation, and traceability to maintain the integrity and reliability of the information.
Conducting a thorough assessment of existing Data Management practices to identify gaps and areas of non-compliance with regulatory requirements. Providing recommendations for enhancements and corrective actions to ensure alignment with ICH M7 and FDA standards. Collaborating with the client to develop and implement remediation plans to address deficiencies and data management capabilities.
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.
