Quality by Design (QbD) provides consultancy services for companies in various industries, such as life sciences (pharma, biotech, medical devices and healthcare), cosmetics and food.
They are not your everyday consultancy partner, because they are experts in their two focal points: medical devices and ATMPs. Thanks to years of experience, QbD is able to help its clients implement and improve quality management and provide support in the optimal validation of products, processes and software. To this end, QbD employs more than 185 specialists in the fields of validation, technology transfer and quality control and has offices in Belgium (HQ), the Netherlands, Spain, France, Mexico and Colombia. For more information, visit www.qbd.eu
You may contact us for advice on:
Validation & qualification: risk-based validation & qualification is the adequate method to prove your product is correctly prepared, packaged, labelled and transported. That’s why each quality control process in the life sciences, healthcare and cosmetics industry needs to contain a certain validation & qualification aspect.
Quality management: this includes complying with various guidelines and legislation – like the GMP guidelines – regarding the development, manufacturing and control of a product – to guarantee its quality. Besides product and service quality, quality management also focuses on the means to achieve this, including the right documentation, equipment and audit preparation.
Regulatory affairs: QbD supports you throughout the entire drug or medical device regulatory lifescycles. Whether this concerns traditional pharmaceuticals, generics, cosmetics, vaccines, biologicals or biosimilars, medical devices or Advanced Therapy Medicinal Products (ATMPs)
Project management & support: Working with QbD means working with strong project managers, experienced in various types of projects. QbD is the full service partner in project management & support for various topics and projects in the field of quality management.
Medical devices: Medical devices are subject to an increasing number of standards, like ISO13485. 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 (ATMPs): production processes in this area are still labour-intensive, open and hardly automatized. There is clearly a growing need to make them more stable, robust and upscalable. In close cooperation with its innovative partner Antleron, QbD aims to answer to this need by ensuring that advanced therapy processes are closed and automatized.