Phoenix Pharma
LabWare
BA Unternehmensgruppe
Reckitt
BIONTECH
ratiopharm
SANOFI
Boehringer Ingelheim
Biotest
Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
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Our service assists companies in evaluating their existing Risk Management processes to ensure compliance with international regulations such as FDA, EMA, and ICH. We assess whether there is a robust risk-based approach integrated into all Quality processes and identify any GAPs or deficiencies in the current risk management framework.
We conduct a thorough review of the Risk Management framework against applicable regulatory requirements and guidelines, including FDA Risk Assessment Framework, ICH Q9, and EMA Risk Management Plans. This involves assessing the alignment of Risk Management practices with regulatory expectations and identifying areas of non-compliance.
Our team maps out the end-to-end risk management process within the organization, from risk identification and assessment to risk mitigation and monitoring. We analyze each step of the process to identify GAPs, redundancies, and areas for improvement, ensuring a comprehensive understanding of the risk management landscape.
We evaluate the extent to which a risk-based approach is embedded across all quality processes within the organization. This includes assessing the integration of risk management principles into activities such as deviation management, change control, validation, and batch release. We provide recommendations for enhancing the implementation of a risk-based approach to drive efficiency and compliance.
Our team collaborates closely with you to create, maintain and improve your Quality Management Systems ensuring a perfect fit between processes and goals. From initial setup to ongoing support, we ensure that every element supports robust holistic compliance, efficiency, and long-term growth.
Zamann is committed to building Quality Management Systems that exceed expectations. With a deep understanding of regulatory requirements and global practical expertise, we ensure not only compliance with regulations, but also optimization of QMS´s workflows and continuous improvement.
