Quality Management Systems (QMS) & Quality Assurance Support

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Promedix Labs delivers tailored Quality Assurance and Quality Management System support to pharmaceutical and life sciences organisations. Our services support a wide range of operations, including API and finished product manufacturing, quality control laboratories, storage and distribution activities, and clinical trial sponsorship.

Our quality support is designed to be practical, scalable, and aligned with current regulatory expectations.

Promedix Labs assists with the design, implementation, and maintenance of effective quality systems across a range of pharmaceutical operations. This includes developing complete quality frameworks for activities such as manufacturing, importation, storage and distribution, and clinical trial support. We also support the creation and revision of quality documentation, including SOPs, quality manuals, production documentation, and system-specific procedures such as deviation management and change control. Where quality systems are already in place, we perform structured gap assessments and provide clear recommendations, including system updates and remediation activities. 

We provide targeted training to support compliance and quality awareness across organisations. This includes training on newly created or revised quality documentation, as well as general GMP and GDP training programmes. Refresher training can also be provided to support ongoing compliance and inspection readiness. 

Promedix Labs supports organisations in preparing for regulatory inspections through pre-inspection audits conducted either on-site or remotely. We assist with addressing identified gaps, supporting sites during inspections when required, and helping prepare responses to inspection findings. Our team also supports organisations seeking new manufacturing or operational authorisations and assists with post-inspection remediation and ongoing compliance improvement programmes. 

We provide flexible Quality Assurance cover to support short-term, medium-term, or long-term operational needs. This includes emergency or planned cover to support business continuity during staff absence or periods of increased workload. 

Promedix Labs assists organisations in adapting quality systems to meet evolving regulatory requirements. This includes reviewing existing practices against new or updated regulations and supporting implementation of changes required to maintain compliance, such as updates arising from clinical trial regulatory changes or post-Brexit requirements.