Our expertise in pharmaceutical engineering, medical devices and digital transformation positions ALTEN as an essential partner for healthcare and life sciences companies.
Manufacturing (Quality Assurance, Qualification, Validation, CSV)
Design of medical devices (classes I to III)
Regulatory Affairs and Pharmacovigilance
Business transformation and digital services
ALTEN Ltd completed the commissioning of two different APIs for a major pharmaceutical company in the UK. With our expertise in process engineering, we provided technical solutions to our customer, supporting manufacturing activities (HAZOP, Standard Work Instructions and Management of Change). We also tested the new installations, equipment & software, and developed non-routine activities between commissioning batches to prevent and correct deviations. We demonstrated leadership in dealing with different stakeholders, ensuring a focus on safety and efficiency.
- Process Engineering
- Data Integrity
- Equipment Validation
- Process Automation
- Continuous Improvement
ALTEN Ltd supported the plant renovation of a multinational health care company in the UK. With our expertise in Project Management and GMP environment, we supported the customer in a challenging phase. By sharing best practices from process engineering experience, we planned the project from concept to delivery. We provided technical and project leadership to our customer, acting as a liaison between stakeholders, designers and construction companies, to coordinate activities around the project.
- Project risk management
- Resource, time and budget control
- EHS and sub-contractor management
- Project coordination
Following a non-conformance identified during the quality control of a manufactured batch of sterile products, ALTEN supported a pharmaceutical company to identify the root cause and implement corrective and preventive measures. The scope of the investigation was to identify production and degradation-related impurities.
After defining the investigation method, we analysed the production conditions and quality control measures & methods. We then identified, implemented and evaluated the efficiency of corrective actions, and proposed additional control measures to detect the risk of impurity entries.
Our understanding of the product principles and our expertise in the market standards enabled us to deliver efficient and long-term actions. Our work significantly helped the customer to get impurity-free and marketable products.