Phoenix Pharma
LabWare
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Reckitt
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ratiopharm
SANOFI
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Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
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Zamann Pharma Support provides consultancy services that assist clients in establishing the essential framework for conducting rigorous quality management reviews in alignment with international regulations, including FDA, ICH Q10, and EMA guidelines. Our approach is designed to ensure that organizations can effectively assess and improve their quality management systems. We work closely with clients to develop policies, standard operating procedures (SOPs), and key performance indicators (KPIs) that support a structured review process. By implementing a strong quality management review framework, companies can enhance product quality and compliance while fostering a culture of continuous improvement.
We conduct a thorough analysis of regulations from the FDA, ICH Q10, and EMA to identify specific requirements relevant to quality management reviews. This comprehensive assessment involves evaluating regulatory expectations regarding documentation and quality management practices. By ensuring alignment with international standards, we enable organizations to understand their obligations and implement necessary changes effectively. Our goal is to equip clients with the knowledge and resources needed to meet these regulatory requirements, thereby enhancing their overall quality management practices. Staying informed about evolving regulations is crucial for maintaining compliance and fostering confidence among stakeholders.
Collaborating closely with clients, we create a comprehensive set of documents designed to support their quality management review needs. This includes developing quality policies, SOPs, and KPIs tailored to meet specific organizational requirements. We employ meticulous drafting and review processes to ensure that the documentation framework not only reflects best practices but also adheres to regulatory expectations. By establishing a solid documentation foundation, we assist clients in systematically tracking quality metrics and improving operational efficiencies. This comprehensive approach provides the necessary tools for organizations to assess and enhance their quality management systems effectively.
We provide guidance on implementing the developed documentation framework, assisting clients in seamlessly integrating it into their quality management systems. This support includes conducting training sessions for staff to ensure they understand the processes and expectations outlined in the documentation. Additionally, we conduct periodic reviews to ensure the documentation remains current and effective in supporting quality management reviews in compliance with FDA, ICH Q10, and EMA regulations. Our ongoing support ensures that organizations can adapt to changes in regulatory requirements, maintaining a proactive approach to quality management and continuous improvement.
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.
