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Market Complaints – GAP Assessment

Our service assists companies in developing robust strategies for managing market complaints in compliance with international regulations. In today’s highly regulated environment, it’s vital for organizations to implement an effective complaints management system. We provide the necessary technical background through the development of comprehensive policies, standard operating procedures (SOPs), and executional templates. These resources equip our clients with the tools and guidance needed to effectively address and resolve market complaints while maintaining regulatory compliance. By focusing on a proactive approach to complaints management, companies can enhance customer satisfaction and build brand loyalty.

Participants engaging in a complaint management workshop focused on regulatory compliance and best practices.

Regulatory Compliance Review

Our team conducts a comprehensive analysis of applicable regulatory requirements and guidelines to establish a baseline for evaluation in complaints management. This thorough review involves examining relevant regulations issued by authoritative bodies such as the FDA, EMA, and WHO to ensure alignment with industry standards. By understanding the specific requirements and expectations set by these regulatory authorities, we help our clients ensure their complaints management practices are compliant and effective. Keeping abreast of regulatory updates and best practices enables organizations to remain competitive while minimizing the risks associated with non-compliance.

Process Evaluation

We assess the effectiveness and efficiency of existing complaints management processes, including procedures for receiving, documenting, investigating, and resolving complaints. This detailed evaluation allows us to identify deficiencies, inconsistencies, and gaps that may exist in the current workflow. By closely analyzing each step of the complaints management process, we can provide targeted recommendations for improvement that help streamline operations. Our goal is to enhance the overall responsiveness and effectiveness of the complaints management system, allowing organizations to resolve issues swiftly and maintain customer trust.

Documentation Analysis

We conduct a thorough review of the adequacy and accuracy of documentation related to market complaints. This includes evaluating complaint handling procedures, investigation reports, and corrective action plans. Our analysis helps determine whether the documentation aligns with regulatory requirements and provides clear evidence of complaint resolution activities. Strong documentation is essential in complaints management, as it serves to protect organizations during audits and inspections. By ensuring that all documentation is accurate and complete, we enable our clients to maintain compliance while facilitating transparent and efficient complaint resolution processes.

Visual representation of a regulatory compliance review for market complaints management.

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.

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