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Siedlerstraße 7 | 68623 Lampertheim, Germany

info@zamann-pharma.com

EudraLex Vol.4 Annex 1 – Routine Support

Zamann Pharma Support GmbH provides hands-on assistance to pharmaceutical companies in executing tasks outlined in their compliance strategy with EudraLex Volume 4 Annex 1 regulations. We offer practical support to ensure seamless implementation of the adaption plan, helping companies meet regulatory requirements and maintain manufacturing quality standards.

a scientist is testing various pills in order to improve their quality an effectiveness in the labor

Task Execution Assistance

On-the-ground support to execute tasks identified in the adaption plan for compliance with EudraLex Volume 4 Annex 1. Our team assists with implementing changes to manufacturing processes, equipment, and facilities, ensuring alignment with regulatory standards and industry best practices.

Documentation Management

We support companies to manage documentation related to EudraLex Volume 4 Annex 1 compliance, including updating SOPs, protocols, and reports as required, ensuring that documentation accurately reflects implemented changes and meets regulatory expectations for completeness and accuracy.

Training and Skill Development

Training sessions and workshops to enhance the skills and knowledge of personnel responsible for executing tasks related to EudraLex Volume 4 Annex 1 compliance.
Our training programs cover topics such as manufacturing best practices, quality standards, and regulatory requirements, empowering employees to perform their roles effectively and contribute to compliance efforts.

Innovative scientific research

EudraLex Vol.4 Annex 1 – Project Management

Scientists working in laboratory

EudraLex Vol.4 Annex 1 – Workshop and Trainings

Customized support for Quality Management Systems

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.

Why Zamann?

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.

Modern Laboratory Work Space

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