By bringing our consultants and their expertise together with our life sciences clients in the best possible way, we help our clients to develop safe therapies and technologies for patients and consumers. We do this worldwide, with over 170 people who are highly qualified in QA, validation, regulatory affairs and project management & support in the pharmaceutical, biotech, healthcare, medical devices and cosmetics industries. To this end, we have set up offices in Belgium (HQ), the Netherlands, Spain, Mexico and Colombia. .
**Validation ** QbD offers an extensive range of validation services for your processes, applications and equipment. Our specialists work in an efficient and well-structured way. Our risk-based approach guarantees the right focus. This way, we enable you to guarantee that your biotech products meet the high quality demands and comply with regulations, and to prove that they are correctly prepared, packaged, labelled and traceable.
Quality Assurance 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.
Regulatory Affairs Quality by Design helps you in your journey throughout the entire drug and medical device regulatory lifecycle. This includes Regulatory Compliance, Artwork & Labelling, eCTD Submissions, Market Authorization, Investigational Fillings, Document Services and Regulatory Dossier. 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.
Project Management & Support Quality and flexibility are key in how QbD gets things done. With more than 175 professional 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 inhouse 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.
**Medical Devices ** 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.
ATMP Advanced therapy medicinal products are becoming a reality, and they will soon revolutionize the biotech industry. But what are ATMP’s exactly? Which 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.