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 GmbH offers comprehensive Audit Readiness services customized to meet the stringent requirements of regulatory agencies such as the FDA and EMA. Our expert consultants ensure that pharmaceutical companies are well-prepared for audits, providing strategic guidance and support to achieve compliance and readiness.
We conduct thorough gap analysis assessments to identify areas of non-compliance and potential vulnerabilities in existing systems and processes. Based on the findings, we develop tailored remediation plans, outlining corrective actions and strategies to address deficiencies and enhance compliance with regulatory standards.
Our team assists clients in reviewing and organizing documentation to ensure completeness, accuracy, and accessibility for regulatory inspections. We provide guidance on the creation and maintenance of audit-ready documentation, including SOPs, validation reports, and quality records, to demonstrate compliance with FDA and EMA requirements.
To simulate real-world audit scenarios, we conduct mock audit simulations designed to assess preparedness and identify areas for improvement. Our consultants facilitate mock audits, closely mirroring regulatory inspection processes, and provide feedback and training to key personnel to enhance their readiness and confidence during actual audits.
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.
