Nuestros servicios y soluciones
Desde 2011, QbD ayuda a las empresas de los sectores de las ciencias de la vida, la sanidad y la cosmética a desarrollar y producir productos con calidad. QbD ofrece a las empresas conocimientos especializados, experiencia y software en los ámbitos de la validación, la garantía de calidad, los asuntos reglamentarios y la gestión y el apoyo de proyectos. Con más de 300 expertos en calidad, QbD es su socio para el asesoramiento y apoyo en el control de los riesgos de calidad.
Servicios por especialidad
QbD ofrece una amplia gama de servicios de validación para sus procesos, aplicaciones y equipos. Nuestros especialistas trabajan de forma eficiente y bien estructurada. Nuestro enfoque basado en el riesgo garantiza el enfoque adecuado. De este modo, podrá garantizar que sus productos biotecnológicos cumplen con las altas exigencias de calidad y con la normativa, y demostrar que están correctamente preparados, envasados, etiquetados y trazables.
QbD offers all QA activities necessary to get your product to the market in a safe and compliant way. We set up, implement and train all necessary procedures to shape your Quality Management System in a compliant and efficient way. We know how to tackle any highly regulated supply chain demand. We even provide QP/RP services in a flexible and tailor made way. QbD really assures quality in a compliant way without losing efficiency and added value out of sight.
Quality by Design helps you in your journey throughout the entire drug and medical device regulatory lifecycle. QbD is able to insource full regulatory affairs projects in an efficient and pragmatic way. Resulting in paper based or fully electronic product submissions that are efficiently managed and compliant with the applicable legislation.
QbD is an expert clinical solutions provider specialized in medical devices and biotech. We offer a unique combination of global CRO services, consultancy, clinical quality services, and training.
QbD offers the first cloud-based and pre-validated Quality Management Software built for Life Sciences. Writing down your quality processes is one thing, but making sure everybody is aware of them and following up on events, CAPAs, and a plethora of related actions is what keeps QA people awake at night. With Scilife™ you can reclaim your peaceful nights again.
Quality and flexibility are key in how QbD gets things done. With more than 300professional quality consultants worldwide, QbD will manage and/or support any QA validation or regulatory project from A to Z. Our broad scientific and professional expertise gives us the flexibility to adapt our approach to the project pace that you desire, taking into account your available in-house resources and budgets. When necessary, QbD easily scales up or down the effort when needed to successfully execute the project. To all this we add transparent reporting via monthly steering committees and weekly working committees.
We offer analytical services in compliance with GMP for testing pharmaceutical raw materials, excipients, and release testing of finished products.
At QbD, we like to pass our expertise on to our clients and partners. That’s why we offer training and coaching for companies, small groups and individuals.
Medical Devices are subject to an ever-increasing number of standards, like ISO 13485. Ensuring their quality, safety and efficacy requires a tailored Quality Management System. QbD offers a wide range of solutions to make sure the production and validation of medical devices are on the right track from day one.
Advanced therapy medicinal products are becoming a reality, and they will soon revolutionize the biotech industry. But what are ATMPs exactly? zWhich opportunities does it have to offer to biotech companies and which pitfalls and regulations will you have to consider when adopting this innovation? QbD is your ATMP expert.
Our way of working
Over 300 experts are ready to advise and support you in the field of validation, regulatory affairs, quality assurance or project management and support. You can entrust your project to our consultants and rely on their skills.
Our Quick Scan includes a thorough on-site risk assessment of your ISO and GxP compliancy. The result is a detailed report, including problem definition, gap analysis and CAPA list with critical actions, which you can tackle alone or with QbD.
We take care of your short and long-term projects in the field of validation, regulatory affairs, quality assurance and project management and support. This accounts to both validation and documentation projects.
Within any regulated quality system, an audit process is required for its approval. This includes both internal and external audits.
We offer highly educated young professionals for your temporary projects. They receive relevant training, while gaining on-the-job experience. For you, it’s the perfect way to efficiently manage projects and resources and you get the chance to hire the trainee yourself after 14 months.