Phoenix Pharma
LabWare
BA Unternehmensgruppe
Reckitt
BIONTECH
ratiopharm
SANOFI
Boehringer Ingelheim
Biotest
Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
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Zamann Pharma Support provides consultancy services for assisting clients in establishing the essential framework, including policies, SOPs, and KPIs, to conduct rigorous Quality Management Reviews in alignment with international regulations such as FDA, ICH Q10, and EMA guidelines.
We conduct a thorough analysis of FDA, ICH Q10, and EMA regulations to identify specific requirements relevant to Quality Management Reviews.
Assessing regulatory expectations regarding documentation and Quality Management practices, ensuring alignment with international standards.
Collaborating closely with clients, we create a comprehensive set of documents including quality policies, SOPs, and KPIs to meet the client’s quality management needs.
We employ meticulous drafting and review processes to ensure that the documentation framework reflects best practices and regulatory expectations.
We provide guidance on implementing the developed documentation framework, assisting clients in integrating it into their Quality Management Systems.
Conducting 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 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.
