Phoenix Pharma
LabWare
BA Unternehmensgruppe
Reckitt
BIONTECH
ratiopharm
SANOFI
Boehringer Ingelheim
Biotest
Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
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Specialized consultancy focused on evaluate the clients’ implemented strategies for compliance with the latest requirements of EudraLex Vol. 4 Annex 1. Our service provides a comprehensive assessment of existing practices, identifying GAPs and areas for improvement to ensure alignment with regulatory standards.
We conduct a thorough review of the latest requirements outlined in EudraLex Vol. 4 Annex 1, focusing on aspects such as manufacturing practices, cleanroom design, and contamination control.
Our experts assess the client’s implemented strategies and practices against these requirements, identifying any deviations or areas of non-compliance.
Zamann conducts a detailed GAP analysis to compare the client’s current practices with the requirements of EudraLex Vol. 4 Annex 1.
We review existing documentation, procedures, and quality records to identify discrepancies or deficiencies in compliance and documentation practices.
Based on the findings from the gap assessment, we provide actionable recommendations and develop a strategic action plan to address identified gaps.
Our team collaborates closely with clients to prioritize corrective actions, implement process improvements, and enhance compliance with regulatory standards.
We provide guidance and support throughout the implementation phase, assisting clients in executing the action plan and ensuring successful alignment with the latest requirements of EudraLex Vol. 4 Annex 1.
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.
