Quality by Design first in Benelux to offer step-by-step plan for qbd projects07/04/2016 - Bart Van Acker, Founder/Managing Director at Quality by Design
Quality by Design joins forces with the Spanish QbD Pharmaceutical Services
Quality by Design (QbD), the expert in quality management for enterprises in the pharmaceutical, biotechnical and cosmetics industries, has entered into a partnership with the Spanish company QbD Pharmaceutical Services S.L., provider of specialised solutions to pharmaceutical and biopharmaceutical companies. From now on, QbD will offer the implementation of SMART QbD – the quality by design method developed by QbD Pharmaceutical Services for the development of treatments – to companies in the Benelux. This cooperation will see both companies combine their expertise and also expand their services in Europe.
Both companies support clients in managing quality risks during product development, production and distribution by offering advice and providing specific knowledge, skills and tools. QbD Pharmaceutical Services is mainly active in the pharmaceutical and biopharmaceutical sector, while QbD operates in the pharmaceutical, life sciences, healthcare and cosmetics industries.
Concrete qbd methodology
This collaboration means QbD is the first company to add the SMART QbD methodology to its portfolio in the Benelux. The methodology is based on the quality by design principle. The general approach – developed by the International Conference on Harmonisation (ICH) – states that quality should be built into a product. Quality is guaranteed if product development is approached in a systematic way with predefined objectives and optimal understanding and control of products, processes and risks. The method is based on scientific research, mathematical models and quality risk management.
SMART QbD allows QbD to offer its clients a proven step-by-step plan for their quality by design projects for the development of new medication or the optimization of industrial processes. SMART QbD applies statistics to corporate data to improve product and process knowledge. It also includes the project management tool DMAIC (SIX Sigma), which allows you to define objectives, resources and constraints, and a risk analysis tool adapted to the different stages of development that is designed to be collaborative to facilitate knowledge sharing. The methodology is supported by the validated QualityKick solution from QbD Software.
Alicia Tébar, CEO QbD Pharmaceutical Services: “We are very pleased with this partnership. QbD only employs qualified, motivated people with a passion for helping companies accelerate and improve their go-to-market process. We are looking forward to a successful cooperation and to helping European clients comply with the various rules and processes.”
Bart van Acker, founder and managing director of Quality by Design: “The partnership with QbD Pharmaceutical Services is a great step forward for QbD. Since 2011, we have been providing support to Benelux companies and their quality management processes, and this new collaboration will enable us to expand our services to the rest of Europe. Thanks to the addition of the SMART QbD methodology to our portfolio, we are the only player in the market to offer all the services under one roof – from validation and quality management to technology transfers and quality by design processes. Moreover, our contacts in Spain give us access to the rapidly growing South American market.”