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 offers specialized consultancy services, aimed at evaluating the compliance level of the implemented landscape governing Quality Management Review activities. With meticulous attention to detail, we assess the effectiveness and alignment of existing processes, policies, and documentation with international regulations and industry best practices.
We conduct a comprehensive analysis of relevant regulations, including FDA, ICH Q10, and EMA guidelines, to identify the necessary standards and requirements for Quality Management Review.
Our experts evaluate the existing documentation and practices against these regulatory benchmarks, identifying gaps and areas for improvement.
We perform a thorough GAP analysis to compare the current state of Quality Management Review processes against regulatory expectations and industry standards. Our team reviews existing documentation, including policies, SOPs, and quality records, to assess their adequacy and alignment with regulatory requirements.
Based on the findings from the GAP assessment, we provide actionable recommendations and develop a tailored action plan to address identified deficiencies and improve compliance. We prioritize corrective actions, establish timelines, and allocate resources effectively to enhance the Quality Management Review landscape.
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.
