Phoenix Pharma
LabWare
BA Unternehmensgruppe
Reckitt
BIONTECH
ratiopharm
SANOFI
Boehringer Ingelheim
Biotest
Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
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In-depth exploration of global regulatory requirements and expectations regarding nitrosamines in pharmaceutical products, including recent updates and emerging trends.
Analysis of regulatory guidance from authorities such as the FDA, EMA, and other relevant regulatory bodies to ensure a thorough understanding of compliance obligations.
We establish digital workflows and protocols for the Periodic Review of computerized systems, ensuring that they remain in a state of control and compliance with evolving regulatory standards.
Additionally, we will take care of the periodic review of Audit Trails, ensuring data integrity and compliance.
Detailed training on risk assessment methodologies specific to nitrosamines, covering hazard identification, risk evaluation, and risk control strategies.
Practical exercises and case studies designed to reinforce understanding and application of risk assessment principles in the context of nitrosamine impurity management.
Guidance on implementing risk mitigation strategies and control measures to prevent or minimize nitrosamine contamination in drug products.
Examination of real-world case studies and best practices from the industry to illustrate effective approaches to nitrosamine risk management and regulatory 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.
