Phoenix Pharma
LabWare
BA Unternehmensgruppe
Reckitt
BIONTECH
ratiopharm
SANOFI
Boehringer Ingelheim
Biotest
Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
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Our specialized consultancy focuses on evaluating clients’ implemented strategies for compliance with the latest requirements of EudraLex Vol. 4 Annex 1. We provide a comprehensive assessment of existing practices, identifying gaps (GAPs) and areas for improvement to ensure alignment with regulatory standards. Through our meticulous approach, we empower organizations to understand the current state of their compliance efforts and take informed steps towards achieving adherence to the latest regulatory expectations. Our expertise helps clients navigate the complexities of Annex 1 requirements effectively.
We conduct a thorough review of the latest requirements outlined in EudraLex Vol. 4 Annex 1, focusing on critical aspects such as manufacturing practices, cleanroom design, and contamination control. Our experts meticulously assess the client’s implemented strategies and practices against these requirements, identifying any deviations or areas of non-compliance. This in-depth regulatory compliance review not only helps ensure that organizations meet the necessary standards but also highlights opportunities for enhancing operational efficiency and product safety. By identifying compliance gaps early, clients can proactively address potential risks.
Zamann conducts a detailed GAP analysis to compare the client’s current practices with the specific 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. This systematic analysis allows us to provide clients with a clear understanding of where their practices may fall short, enabling targeted corrections. By ensuring that documentation is thorough and aligned with regulatory expectations, organizations can bolster their credibility and readiness for audits.
Based on our findings from the GAP assessment, we provide actionable recommendations and develop a strategic action plan to address identified gaps in compliance with EudraLex Vol. 4 Annex 1. Our team collaborates closely with clients to prioritize corrective actions, implement process improvements, and enhance overall compliance with regulatory standards. We offer ongoing guidance and support throughout the implementation phase, assisting clients in executing the action plan to ensure successful alignment with the latest requirements of the Annex. This collaborative effort fosters a culture of continuous improvement and regulatory compliance within the organization.
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.
