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 aiding clients in developing strategies to adapt to the latest requirements outlined in the revised EudraLex Vol. 4 Annex 1. We assist in creating a comprehensive pathway for the adaptation project, ensuring alignment with regulatory standards and industry best practices.
We analyze the updated requirements related to microbiological quality, including microbial monitoring, environmental monitoring, and control of microbial contamination.
Our experts assist in developing strategies for implementing robust microbiological control measures to ensure product quality and compliance with Annex 1.
We provide guidance on the enhanced requirements for aseptic processing, including validation of aseptic processes, facility design, and personnel training. Our consultancy assists in developing strategies for implementing advanced aseptic techniques and technologies to meet the standards set forth in the revised Annex 1.
We help clients establish comprehensive contamination control strategies, addressing aspects such as cleanroom design, sterilization processes, and control of particulate and microbial contamination. Our team collaborates with clients to develop approaches for mitigating contamination risks and ensuring product quality, safety and efficacy.
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.
