Phoenix Pharma
LabWare
BA Unternehmensgruppe
Reckitt
BIONTECH
ratiopharm
SANOFI
Boehringer Ingelheim
Biotest
Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
Menu
Our service assists companies in evaluating their existing risk management processes to ensure compliance with international regulations such as FDA, EMA, and ICH. In a rapidly changing regulatory landscape, it is crucial for organizations to adopt a proactive approach toward risk. We assess whether a robust risk-based approach is integrated into all quality processes, including production, testing, and distribution. Furthermore, we identify any gaps or deficiencies in the current risk management framework that may hinder compliance or expose the organization to unforeseen vulnerabilities. By closing these gaps, we help our clients not only achieve compliance but also enhance their overall operational efficiency.
We conduct a thorough review of the risk management framework against applicable regulatory requirements and guidelines, including the FDA Risk Assessment Framework, ICH Q9, and EMA Risk Management Plans. This meticulous assessment involves examining the alignment of current risk management practices with regulatory expectations, focusing on identifying areas of non-compliance that could lead to regulatory penalties or product recalls. Our deep understanding of industry regulations allows us to provide actionable recommendations for aligning with best practices. By ensuring compliance with these standards, we help organizations safeguard their reputation and maintain customer trust in their products and services.
Our team maps out the end-to-end risk management process within the organization, from risk identification and assessment to risk mitigation and continuous monitoring. This comprehensive process mapping allows us to analyze each step in detail, identifying potential gaps, redundancies, and areas that require improvement. By ensuring a detailed understanding of the risk management landscape, we can recommend targeted strategies that focus on enhancing efficiency and compliance. We leverage our expertise to simplify complex processes, providing our clients with a clear roadmap for optimizing their risk management systems and ensuring alignment with organizational objectives.
We evaluate the extent to which a risk-based approach is embedded across all quality processes within the organization. This assessment includes a thorough examination of how risk management principles are integrated into key activities, such as deviation management, change control, validation, and batch release. By identifying strengths and weaknesses in how these activities incorporate risk considerations, we can provide targeted recommendations for enhancing the implementation of a risk-based approach. Our goal is to drive efficiency, compliance, and quality assurance throughout the organization while fostering a culture of proactive risk mitigation that will support long-term success.
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.
