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Quality Assistance: Navigating Excellence in Pharmaceutical Compliance and Innovation

Quality Assistance

In the pharmaceutical industry, ensuring product quality and regulatory compliance is paramount. Companies often turn to Contract Research Organisations (CROs) for expert guidance through the complex regulatory landscape.

Quality Assistance is a leading CRO specialising in providing all necessary analytical services mandated by EMA and FDA regulations for the development and marketing of innovative human medicinal products. With cutting-edge facilities, product-specific expertise and a team of skilled scientists, they offer tailored solutions in terms of analytical protocols and innovative technologies throughout the development process.

With over 40 years of experience, steadfast reliability, and financial stability, Quality Assistance is the go-to analytical partner for both large corporations and SMEs in the pharmaceutical industry.

Insights Care recently had an enlightening conversation with its CEO Nathalie Draux, shedding light on the organisation and her pivotal role in its growth.

A Family Legacy

On 1 January 2023, Philippe Draux entrusted his position of CEO of Quality Assistance to his daughter, Nathalie Draux. Philippe Draux now focuses on his role as Executive Chairman of the Board of Directors. Philippe Draux, industrial pharmacist by training, co-founded the company in 1982 and successfully managed it for 40 years. Ten years after its creation, Quality Assistance settled in Thuin (Belgium) where it has continued its organic growth to this very day.

Nathalie Draux, an industrial pharmacist as well, began her career in the family business over 20 years ago. She has occupied various operational and strategic positions within Quality Assistance. Nathalie Draux has made her way throughout the company by working in the Laboratories, and the Quality Assurance, Training, Regulatory Affairs, Business Development, and Strategy & Innovation teams. This operational experience in the company combined with a Management Programme from the Vlerick Business School have allowed her to successfully fulfil the position of COO from 2016 until 2022 and then CEO since 2023.

Accelerating Innovation and Advancing Public Health

As an analytical CRO, Quality Assistance provides the pharmaceutical industry with all the analytical services required by EMA and FDA regulations in order to help develop and market innovative human medicinal products.

Its team of 250 talents works as a real partner, expanding its clients’ R&D capabilities by offering additional expertise and capacities in a full GxP compliant environment. More precisely, they develop and apply specific and dedicated methods in order to obtain Quality, Safety and Efficacy data on the new drug products that they analyse.

Quality Assistance’s vision is to speed up people’s access to new medicines. The company is always at the forefront of analytical sciences and is committed to providing the highest quality services.

Its clients rely on Quality Assistance to accelerate Time to Market. Since 2015, their teams of experts have contributed to the development of more than 600 innovative drugs, some of which are now on the market.

Analytical Excellence in Medicinal Product Development

Quality Assistance occupies a unique position in the CRO market by providing on a single GxP site all the analytical services required from candidate selection to marketing authorisation, and even beyond. Its clients appreciate having all the laboratories, expertise, Quality system, sample management and resources they need under one roof, as well as a single team dedicated to their project. With more than 40 years experience, proven reliability and stability in the scientific, organisational and financial domains, Quality Assistance stands as the benchmark analytical partner for large companies and SMEs.

The company now counts more than 250 highly qualified team members and actively supports 70 to 100 clients every year. It achieved a turnover of 26.8 million EUR in 2022, 77% coming from exports, and its compound annual growth rate (CAGR) exceeded 10% over the past 5 years.

Quality Assistance is an expert in the development of the most innovative medicinal products such as biotherapeutics (monoclonal antibodies, conjugated antibodies, ADCs), new chemical entities, peptides, therapeutic oligonucleotides, mRNA, viral vectors, vaccines, cell and gene therapies and nanomedicines.

Analytical Support for Innovative Medicines and Beyond

Innovation and excellence are at the core of its development strategy.

Quality Assistance constantly strives to provide full and reliable analytical support for innovative medicines. In addition to its contracted R&D activities, it deploys a strong in-house R&D and Innovation strategy. Dedicated experts perform regulatory, scientific, and technological monitoring which they then translate into projects to acquire new analytical skills in order to address clients’ needs and challenges.

The company is dedicated to offering a comprehensive package of analytical services covering every targeted product. This includes cutting-edge products such as mRNA, viral vectors, and cell and gene therapies for which its R&D focus has flourished in recent years. As a result, they have pioneered novel analytical methodologies, not just to address the current market requirements but to proactively forecast future demands.

Integral to its commitment is the investment in state-of-the-art equipment. Quality Assistance reinvests between 10% and 15% of its turnover each year in the development of its analytical expertise and operational equipment.

Furthermore, its R&D and Innovation department and Scientific Data Management team have been the driving force behind the implementation of Analytical Quality by Design and Analytical Method Lifecycle Management paradigms, both of which are pivotal in the realm of pharmaceutical development.

A sustainable company

In full alignment with the European Corporate Sustainability Reporting Directive (CSRD) and the United Nations’ 17 sustainable development goals, beyond its essential role in public health, Quality Assistance has defined a “We Care We Act” programme that outlines 4 pillars, each including numerous initiatives:

  • Public Health: its contribution to public health, the information and understanding of topics related to health, medicines, the pharmaceutical sector, and analytical sciences.
  • Responsible care: its eco-responsible investments and reduction of its environmental impact in order to become carbon-neutral by 2030.
  • Happiness: its commitment to the well-being and development of its team members.
  • Community: its support of its community and humanitarian causes.

Unveiling Ambitious Expansion Project

In order to meet the growing client demands, Quality Assistance continues to develop its expertise and services, and reaffirms its strategy of centralising them on a single location.

The current MITOSE expansion project, whose name refers to DNA replication, aims to double its facilities from 6,000 to 12,000 m² and to create 100 new highly qualified jobs. This 4th expansion will be operational early 2025. It will allow Quality Assistance to increase its operational capacity and to pursue ambitious strategic objectives. With this new infrastructure, along with its Knowledge Management Programme, Quality Assistance plans to create a Pharma Academy in order to develop the pharmaceutical, regulatory, scientific, and analytical expertise as well as the interpersonal skills of its team members.

Notable Recognitions

  • In 2023, Quality Assistance was awarded the bronze medal from Ecovadis, a third-party rating platform that assesses Environmental, Social, and Corporate Governance.
  • In 2022, Philippe Draux and Nathalie Draux were both awarded the decoration of Officer of the Order of Merit by the Walloon government for the company’s, its leaders’ and its staff’s daily commitment to the benefit of public health.



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