Phoenix Pharma
LabWare
BA Unternehmensgruppe
Reckitt
BIONTECH
ratiopharm
SANOFI
Boehringer Ingelheim
Biotest
Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
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Expert guidance and strategic consultancy services for EudraLex Vol.4 Annex 1 compliance, guiding pharmaceutical companies in establishing the framework necessary to adhere to EudraLex Vol.4 Annex 1 requirements. This service focuses on providing expertise to create a robust landscape for compliance, including the development of essential SOPs and the evaluation of existing processes for improvement.
Conduct a thorough review of existing processes and procedures against EudraLex Vol.4 Annex 1 requirements to identify GAPs and areas for improvement. This involves assessing current practices, documentation, and infrastructure to determine compliance readiness.
Collaborate to develop customized documents aligned with EudraLex Vol.4 Annex 1 guidelines, to define the necessary steps and protocols for maintaining compliance with requirements, covering aspects such as cleanroom design, personnel hygiene, and environmental monitoring.
Provide comprehensive training sessions and workshops to educate the necessary personnel regarding the newest requirements and best practices. This includes training on proper cleanroom behavior, aseptic techniques, contamination control measures, and documentation practices to ensure effective implementation and compliance adherence.
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.
