Our Solutions
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End-to-End Lifecycle Management
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Maximizing your product’s lifecycle performance is key to extract as much value as you can from the investment made. This calls for a holistic approach that allows you to manage your products and related information across the enterprise.
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Quality by Design Frameworks
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Improved time-to-market, better product quality, regulatory compliance, cost reduction, less waste, and cycle time reduction. Quality by Design supports it all. Having a solid Quality by Design framework supported by the latest technology will have a major impact in your business operations. Our decade of experience and proprietary state of the art software can help you.
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PAT Implementation Services
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Maximizing your product’s lifecycle performance is key to extract as much value as you can from the investment made. This calls for a holistic approach that allows you to manage your products and related information across the enterprise.
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Computer System Validation
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Maximizing your product’s lifecycle performance is key to extract as much value as you can from the investment made. This calls for a holistic approach that allows you to manage your products and related information across the enterprise.
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Root-Cause Analysis and Corrective and Preventive Action
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Process Deviations are intricate. When your process is not yielding what you expected, when you have tried different ways to solve it and the process deviation remains, you probably need a different approach. We can help.
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Process Scale-up Strategy and Implementation
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It's time to make your risk assessments easier, streamline your operations and improve your reporting. And most importantly, you will use your resources better. What are you waiting for?
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Continuous Manufacturing Support and Implementation
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Maximizing your product’s lifecycle performance is key to extract as much value as you can from the investment made. This calls for a holistic approach that allows you to manage your products and related information across the enterprise.
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Quality Risk Management Process Optimisation
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It's time to make your risk assessments easier, streamline your operations and improve your reporting. And most importantly, you will use your resources better.
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Nitrosamine Risk Management
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Nitrosamines in batches of products containing Sartan derivative, Ranitidine or Metformin are a cause of concern. Regulatory agencies expect you to submit a Risk Evaluation Report as well as an action plan to deal with identified risks. To support you with this, 4TE delivers Quality Risk Management Optimisation built on top of our Consultancy services and QRM digital platforms.
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Medical Cannabis Risk Assessment & Management
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The pharmacology of cannabis is complex due to specific risks related to the wide range of naturally occurring compounds. As the industry evolves, it is expected that GMP compliance and certification will become the standard similarly to the food and pharmaceutical sectors. However, having a complete understanding of existing regulations (regional and global) and business risks involved in obtaining GMP certification can be challenging. To help you with this, 4TE provides our expertise in Quality Risk Management (QRM) built on top of our Consultancy services and QRM digital platforms.
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Cell & Gene Therapy Digital Risk Management
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Cell and Gene Therapies (CGT) have advanced significantly in recent years, with more companies investing in this type of products. As with all product development processes, risk management has an important role on demonstrating patient risk mitigation. To help you with that, 4TE delivers specialized Quality Risk Management (QRM) for CGT built on top of our consultancy services and QRM digital platforms.
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Quality Risk Management Process Digitalisation
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Easy Risk Assessments, Streamlined Operations and improved reporting. And most importantly, you will use your resources better.
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Custom-made Pharma Software
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Sometimes you need a solution different from the standard market offer. We have experience designing, building and implementing custom-made software for leading Pharmaceutical, Biotech and Medical Firms. We’ll help transform your business.
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Digital Continued Process Verification
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The manual Continued Process Verification (CPV) implementation is a slow and resource-consuming process. Implementing a digital CPV can yield benefits in automatic data capture, organisation, visualisation and reporting, substantially improving your Quality Assurance and reducing massively the time and resources necessary for it to happen. 4TE can support the digitalisation of your Continued Process Verification and with it help you reduce your costs and enable a real-time verification that your process is within a state of control.
