OUR STORY
Empowering Radiopharma Through Expert Consultation
With over two decades of radiopharmaceutical experience, Qualificiency stands at the forefront of radiopharmaceutical process-driven design, guiding projects from conception to operation. Our expertise ensures that your radiopharmaceutical development, production, quality and delivery processes are efficient, compliant, and innovative.
We provide comprehensive strategic consultancy services to help you navigate the complexities of radiopharmaceutical production from a user prspective. Our team of experts collaborates with you to develop tailored strategies that align with your goals and regulatory requirements.
Our approach to operational design is rooted in process efficiency and effectiveness. We optimise your development, production, quality and delivery processes, ensuring seamless integration and maximum productivity, while ensuring and maintaining compliance.
We handle procurement and cost management with precision, ensuring that you receive the best value for your investments. Our procurement strategies are designed to optimise costs without compromising on quality, nor compliance.
We provide GMP lifecycle validation services to ensure that your processes, facilities and delivery comply with Good Manufacturing and Good Distribution Practices. Our validation services cover all stages of the lifecycle, from initial concept and qualification to ongoing monitoring and final decommissioning.
Navigating the regulatory landscape can be challenging. Qualificiency offers regulatory compliance services to help you meet all necessary regulations and standards. Our team stays up-to-date with the latest regulatory changes to ensure that your operations remain compliant in an efficient manner.
We envision a future with broad therapeutic possibilities to enable a long and healthy life for people all over the world. We strongly believe that radiopharmaceuticals will take a major part in this future and therefore we want to contribute to that with helping clients as the one-stop-shop for consultancy services over the whole radiopharmaceuticals lifecycle.
We have over 20 years experience in the radiopharmaceutical industry. We leverage this experience and gathered knowledge by helping our clients with realizing their projects and improving their processes, while taking care of latest regulatory, technical and quality requirements. With that we ensure that radiopharmaceuticals can be manufactured and supplied by our clients with efficient, safe and compliant operated sites and processes.
Service overview
We specialize in providing tailored training for radiopharmaceutical companies and their suppliers. Our programs focus on ensuring compliance, delivering high-quality results, and optimizing efficiency. Unlike generic theoretical courses, our customized training is designed to meet your specific needs, helping your team navigate industry standards and excel in every aspect of production and delivery.
Either if you need a newly developed production process, want to evaluate the feasibility of your ideas or want to improve your established processes we can provide the right expertise. Also if you want to implement or improve your management processes and your material flow we can assist with various experience in e.g. lean management and six sigma.
With growing regulatory requirements it gets more complex to bring a product to the market. If you want help to build up knowledge in regulatory topics like FDA CFR 21, GMP or mandatory quality management we can provide you with tailored training or we gladly assist you with the necessary work.
Unique approach
What makes us stand out in the industry is the capability of providing you with assistance or a solution for every phase of your project or routine operations. From providing you with a building up to handing you over validated and ready to operate processes, until implementing improvements to your operations. While hands-on projects is a major part of our services we can also help you with the early evaluation of your plans.
Everything we do is aimed to an excellent solution for you as our client and your customers. If you need assistance in setting your requirements for a project, we can step in to ask the right questions to clarify your needs and can use our broad network in the radiopharmaceutical world to provide you with the right suppliers and experts to drive your project.
Why work with us
Whether you need help with the development of targeted radiopharmaceuticals, radiochemistry in general, in regulatory, quality, production efficiency, packaging or other topics related to radiopharmaceuticals we can connect you with the right persons from our company or our network.
Dedicated equipment and services are sometimes hard to purchase. Either we can provide you the right services or we leverage our experience with several suppliers all over the world. We help you choosing the right supplier and connect you with them or we drive the purchasing process on your behalf.
We can connect you with the right people and companies to make your plans become reality and interact as a connection point that evaluates your requirements and translate them to specifications.