Phoenix Pharma
LabWare
BA Unternehmensgruppe
Reckitt
BIONTECH
ratiopharm
SANOFI
Boehringer Ingelheim
Biotest
Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
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Our service is meticulously crafted to assist pharmaceutical organizations in establishing robust Quality Management Systems (QMS) aligned with international standards set forth by regulatory authorities like the FDA, EMA, and WHO. We specialize in creating all essential documentation elements necessary for a comprehensive QMS, including guides, policies, SOPs, and templates for activities execution.
We conduct a thorough analysis of your organization’s existing processes, identifying the necessities and deficiencies.
After this comprehensive assessment, we determine the specific requirements and objectives of your QMS implementation, ensuring alignment with regulatory standards.
Our team of experienced consultants collaborates closely with your organization to develop customized Standard Operating Procedures (SOPs) created to your specific operational needs.to your specific operational needs.
We adhere to regulatory guidelines and best practices, ensuring that SOPs are comprehensive, clear, and compliant with FDA, EMA, and WHO requirements.
We facilitate the review and approval process for all QMS documentation, engaging stakeholders across departments to ensure accuracy, consistency, and alignment with organizational objectives.
Our consultants provide guidance on establishing robust documentation control procedures, including version control, change management, and document lifecycle management.
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.
