Company cases we work with

QUALITY IN PRACTICE Different challenges. The same goal: Quality that works. CASE 01 · MEDTECH From technology company to structured medical device Quality system A growing technology company preparing to operate within the medical device environment needed more than a collection of SOPs. It needed a Quality system that connected its existing way of working with the requirements expected of a medical device organisation. OZQA supported the development of a practical QMS covering areas such as document management, training, risk, suppliers, production, change control, CAPA, audits and management oversight. Quality processes were translated into digital workflows so responsibilities, records and activities could be managed as part of one connected system. The objective was not to introduce unnecessary bureaucracy, but to create a scalable Quality foundation that could support the organisation as it moved towards certification and future medical device activities. ISO 13485 Quality Systems Risk Management Digital Quality Explore Medical Device Quality → CASE 02 · PHARMA & BIOTECH Building Quality before clinical development accelerates Early stage pharmaceutical and biotechnology companies often reach a point where informal processes and individual documents are no longer enough. OZQA helps organisations establish the Quality foundation needed as they move towards or through clinical development. This can include Quality governance, controlled documentation, training, risk management, supplier and CRO oversight, deviations, CAPA, change control and audit readiness. Rather than implementing a large pharmaceutical QMS from day one, the system is designed around the company's current stage and built so it can expand as clinical programmes, external partners and regulatory responsibilities increase. Clinical Quality GCP QMS Sponsor Oversight Explore Pharma & Biotech → CASE 03 · QMS REMEDIATION Turning disconnected Quality documents into a working system Having SOPs does not necessarily mean having a functioning Quality system. OZQA supports organisations where Quality documentation has developed over time but processes have become disconnected, inconsistent or difficult to operate. We review what is already in place, identify the most important gaps and keep useful elements rather than rebuilding everything unnecessarily. The result is a more coherent system where documentation, responsibilities, training, risk, CAPA, changes and oversight work together and employees can understand how Quality operates in practice. Gap Assessment QMS Remediation Process Improvement Training Explore QMS Improvement → CASE 04 · COSMETICS Bringing a specialised skincare product towards compliant market entry Bringing a cosmetic product to market requires more than a finished formulation. Product classification, safety documentation, product information, claims and regulatory activities all need to align before launch. For a specialised wound care cream, OZQA supported the regulatory pathway and cosmetic registration activities needed to prepare the product for market. The work focused on creating structure around the required product information and ensuring that the regulatory activities were coordinated efficiently. This type of support is particularly valuable for smaller companies that have strong product expertise but do not need a permanent internal regulatory function. Cosmetics Product Registration Regulatory Support Market Readiness Explore Cosmetics Support → CASE 05 · OTHER INDUSTRIES Building a practical QMS around an innovative biological product Quality systems are not only relevant to pharmaceutical and medical device companies. For an organisation working with lactic acid bacteria, OZQA supported the establishment of a structured Quality Management System that could provide clearer processes, responsibilities, documentation and oversight while remaining proportionate to the organisation and its activities. Instead of importing unnecessary pharmaceutical complexity, the Quality framework was built around the company's actual operations and the level of control needed to support growth, consistency and external expectations. Quality Management QMS Process Control Other Industries Explore Other Industries →