Nathalie Draux: Upholding a Legacy of Excellence at Quality Assistance

In the continuously evolving sector of pharmaceuticals and biotechnology, the quest for innovation and excellence in analytical services plays an integral role in advancing global health solutions.

In this domain, companies like Quality Assistance play an essential role for the pharmaceutical industry by being at the forefront of analytical sciences. Quality Assistance’s passion to advancing public health via cutting-edge research and development is demonstrated by its commitment to scientific rigor, client partnerships, and societal impact. This becomes possible with the impeccable leadership of Nathalie Draux, CEO of Quality Assistance.

Nathalie Draux’s career path has been profoundly influenced by her parents. As a teenager, she spent considerable time at the back of a pharmacy with her mother, a pharmacist, and her father, an industrial pharmacist and company founder. Her interest in science, health, pharmacy, and medicines undoubtedly stems from this family environment. Her parents also instilled in her an awareness and appreciation for the effort and sacrifices required to achieve one’s goals.

Nathalie began her career with a Master’s degree in Pharmaceutical Sciences from UCLouvain in Belgium, followed by a Diploma in specialized studies in industrial pharmacy and an internship at GSK, which enabled her to obtain the status of Qualified Person. She first started working in 2001 at the heart of the family company’s laboratories. Over the next 20 years, she held more than a dozen different positions in almost every department of the company. Nathalie gradually transitioned from serving as a stopgap to becoming a versatile leader, learning most of the company’s trades and developing her leadership skills. After completing a fast-track management training at Vlerick Business School, she became COO in 2016 and took over as CEO of Quality Assistance in 2023, succeeding her father.

Empowering Pharmaceutical Innovation

As a leading analytical CRO, Quality Assistance’s goal is to accelerate people’s access to new medicines. The company is committed to providing pharmaceutical and biopharmaceutical companies with all the analytical services required by EMA and FDA regulations for the development and marketing of its innovative medicinal products.

Each client project is unique and requires customized solutions in order to evaluate the Quality, Safety and Efficacy of the given drugs. Quality Assistance therefore works closely with each of its clients, as an extension of their own team, to provide them with all the support they need.

More than just a service, Quality Assistance offers the support of a committed, respectful team that excels at what it does.

There are many keys to having and keeping a team that is so closely aligned with the company values. The recruitment process, for example, is very important according to Nathalie; it must assess the skills as well as the behaviour and motivation of candidates. Then, it is key to offer training, both upon hiring and on an ongoing basis, tailored to the company’s high standards and services. The team is proud of its work and is aware of the impact it has, directly or indirectly, on the projects that pass through its hands, and therefore ultimately on human health.

Since 2015, its teams of experts have contributed to the development of more than 600 innovative drugs, some of which are now on the market. These new therapeutic molecules are involved in the treatment or prevention of chronic, debilitating, rare, or fatal diseases, including many types of cancer, endocrine diseases, neurodegenerative diseases, viral and bacterial infections (e.g. SARS-CoV-2, AIDS), autoimmune diseases, inflammatory diseases, metabolic diseases, genetic diseases, and other disorders and conditions.

Quality Assistance’s team is sincerely proud to play an essential role in public health and very conscious of the responsibility the organization has towards its clients and the community.

A Legacy of Healthcare Excellence

The company was founded in 1982 by Philippe Draux, Nathalie’s father and his friend, Philippe De Raeve. They started in a rudimentary location in Lodelinsart, Belgium. Then in 1985, they moved to larger premises of about 200 m², occupying the top floor of a building in Charleroi. At that time, the company’s business was essentially focused on the quality control and release of commercial batches of chemically synthesized drugs.

In 1992, it settled in Donstiennes, which remains the company’s current location. This was the decisive step in the development of Quality Assistance. Its new facilities better suited the company’s needs, allowing it to increase its capacity and therefore providing a more credible showcase to expand its client portfolio. Above all, Quality Assistance had embarked on a change of direction in its value proposition, focusing on the most innovative products right from the start of its development.

Since then, the company has experienced constant growth with two subsequent expansions of its operational capacities to reach 6,000m² today. Over more than 40 years, Quality Assistance has grown from 3 to 250 employees forged a solid reputation at the international level, and is now positioned as a preferred partner for the innovative pharmaceutical industry in Europe.

Last year, Quality Assistance achieved a turnover of €29.6M, 74% of which came from exports, and a compound annual growth rate (CAGR) of 9% over 5 years.

Navigating Turbulent Waters

The last 5 years have been extremely challenging for Nathalie, as COO and then CEO. There has been a succession of major international crises (COVID-19, the Russian-Ukrainian war, record-breaking inflation, etc.), all of which have had to be managed and overcome.

But crisis after crisis, the company’s choices have been validated and reinforced, and Nathalie has helped the company stay at the top during this uncertain global climate.

Today, Quality Assistance operates in a fragile economic and geopolitical context. Financing the development of new drugs has become increasingly difficult for pharmaceutical companies, particularly smaller biotechs. Consequently, the European pharmaceutical market is slowing down, subcontracting is decreasing, and service companies are experiencing reduced activity. In 2023, some European CDMOs saw their orders fall by between 20% and 50%.

For Quality Assistance, the impact of this slowdown on its results has been controlled and ultimately very limited. Its strategic choices, the recognition and trust of its clients and partners, financial stability and solidity, extensive experience, and the perseverance of its team have enabled it to weather the storms and prepare it to overcome the challenges that lie ahead.

Excellence in Analytical Services

Nathalie underlines the commitment and quality of the work of each team member on a daily basis, expressing her gratitude for their collective efforts that have made a real difference. She emphasizes the importance of having a happy, reliable, and committed team of a human scale, acknowledging how precious and rare it is to be able to rely so heavily on a subcontractor.

More practically, Quality Assistance occupies a unique position in the CRO market by providing, under one roof, a complete package of analytical services covering EMA as well as FDA requirements for the development of innovative products: biotherapeutics (e.g. mAbs, ADCs), new chemical entities, oligonucleotides, peptides, mRNA, viral vectors, cell and gene therapies, and nanomedicines. Specific to the medicines developed, Quality Assistance is able to design customized solutions, define analytical protocols, as well as develop, validate, and apply specific new analytical methods for each client project.

Its comprehensive range of analytical services is fully GMP, GLP, and GCLP compliant.

The company is 42 years old! This long story has allowed it to demonstrate reliability and stability in the scientific, organizational, and financial domains, and to become a true benchmark for large companies and smaller biotechs.

In taking over as CEO, Nathalie has deliberately chosen to maintain continuity from a business management perspective. This continuity is natural and reassuring for her team, but it’s also essential for clients. The company works with clients on their development projects from the pre-clinical stage, and it takes a long time to get to market. It’s therefore critical for clients to know that Quality Assistance will be there from start to finish with the same value proposition.

Embracing Scientific Innovation and Digital Transformation

The investment in state-of-the-art equipment is integral to Quality Assistance’s commitment to its clients’ needs and to public health. The company reinvests between 10% and 15% of the turnover each year in the development of its analytical expertise and operational equipment. Its teams mobilize a wide array of cutting-edge equipment for the acquisition and interpretation of the data necessary for clients to submit the registration file to the competent authorities. Every technological acquisition is made in order to seamlessly integrate these services within a fully GxP-compliant environment. Complying with the FDA 21 CFR part 11 is a real challenge as software is more and more sophisticated and cloud-based.

In terms of recent advancements, Quality Assistance’s team has integrated techniques such as Multi-Attribute Monitoring of Biotherapeutics, mRNA, and adeno-associated viruses through high-resolution mass spectrometry and Multi-Angle Light Scattering, as well as Flow Cytometry for precise cell phenotyping, digital PCR tailored for AAV characterization, and Next-Generation Sequencing (NGS) dedicated to mRNA identity testing.

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. Both paradigms have now become pivotal in the realm of pharmaceutical development.

The most intense and critical development for Quality Assistance and for the pharmaceutical sector today is the integration of digital and artificial intelligence tools into all processes while ensuring the protection of information and cybersecurity. The company has defined a Digital Roadmap that it is implementing in order to meet the requirements of the authorities, of its clients, and of its talents. It’s a significant investment, a real transformation, essential to maintaining Quality Assistance’s leadership position.

In 2023, Quality Assistance was awarded the bronze medal from Ecovadis, a third-party rating platform that assesses ESG compliance according to four pillars: Environment, Labor & Human rights, Ethics, and Sustainable procurement.

The company is honored by this recognition as it thrives to have a concrete, positive, and global impact on its team members, society, and the planet.

Over the past 20 years, Quality Assistance has implemented numerous environmental, social and governance initiatives. In 2021, it established its We Care We Act program with the aim of gathering all the responsible initiatives the company has been undertaking beyond its core business. These have long been part of its DNA and overtime have been connected to most of the United Nations’ 17 Sustainable Development Goals (SDGs) and are demonstrated in 4 areas:

Public health: How Quality Assistance contributes to public health and plays a role in the information and understanding of topics related to health, medicines, the pharmaceutical sector, and analytical sciences
Environment: How it strives to reduce its environmental footprint and embrace renewable energy sources
Happiness: How it cares about the happiness, well-being, and development of its team members
Community: How the company’s social role and commitment translates into creating even more value for the communities it supports

Championing ESG Excellence

In 2022, Nathalie Draux and her father were both decorated as Officers of the Order of Merit by the Walloon government for Quality Assistance’s and its leaders’ and staff’s daily commitment to the benefit of public health. On the same day, they celebrated the company’s 40th anniversary with the entire team.

Nathalie is proud of all that Quality Assistance and her team have achieved since 1982 and of the many groundbreaking projects currently underway. She is particularly excited this year about the MITOSE expansion project, whose name refers to DNA replication. She plans to double Quality Assistance’s capacity in 2025, reaffirming its strategy of centralizing its offering of analytical services at a single location. The company is leaving the SME status and joining the major European research companies.

This expansion will help in increasing its operational capacities by 50% and pursue ambitious strategic objectives. With this new infrastructure, along with the Knowledge Management Program, Quality Assistance plans to create a Pharma Academy to develop the pharmaceutical, regulatory, scientific, and analytical expertise as well as the interpersonal skills of its team members to meet growing client demands. Additionally, the company will continue to develop its expertise and services dedicated to emerging markets such as messenger RNA, products of cell and gene therapies, and viral vectors.

Leaving a Lasting Legacy

With a total budget of €25 million, Nathalie emphasizes that Quality Assistance is investing not just in a building, but resolutely in its value proposition and its commitment to public health. She notes that, on one hand, innovative therapies, regulations, analytical sciences, and associated technologies will continue to evolve continuously and rapidly. On the other hand, an increasing proportion of the development of new medicines is being handled by small and medium-sized companies. These two factors will increase the need for external expertise and partners such as Quality Assistance.

Nathalie states that Quality Assistance is determined to strengthen its position as a benchmark expert and a competent and reliable partner for its clients. The company is investing significantly to continuously develop its knowledge, service offerings—particularly in data enhancement using the power of AI—and its analytical services capabilities.

Nathalie will continue to look after Quality Assistance and her Team, staying the course, to achieve the objectives the company has set for its shareholders, its clients, Team, and more broadly, through its profession, for the community. Nathalie aims to leave a significant legacy behind, just like her father did.