Founded in 2011 and headquartered in Belgium, QbD Group is a trusted European gateway and strategic partner for companies of all sizes—from startups to global leaders. QbD Group supports clients active in Pharma, Biotech, MedTech, and In Vitro Diagnostics. “Our mission is clear,” says Bart Van Acker, QbD Group CEO. “We help companies accelerate development, achieve and maintain regulatory compliance, and maximize asset value throughout the entire product lifecycle—so they can go from idea to patient impact.”
Supporting a product’s full lifecycle
From the very first spark of an idea to the moment a product reaches patients—and well beyond—QbD Group supports every step of a client’s journey. The Group’s integrated teams bring together regulatory, clinical, and quality expertise, working closely with companies to address the complexities of early-stage strategy, clinical execution, initial market submissions, and ongoing post-market surveillance.
QbD Group’s approach is proactive and transparent, designed to hit critical milestones while managing risks and ensuring that products remain compliant and market-ready long term. “By combining deep expertise with a collaborative and flexible approach, we help our clients bring their innovations to patients faster and more efficiently,” says Van Acker.
Embedding compliance into operations
Operational compliance is a critical pillar of success in the life sciences. Beyond regulatory approvals, products must be backed by robust quality systems, validated processes, and efficient manufacturing operations. QbD Group helps clients embed these essentials into their business operations from qualification and validation of equipment and facilities, through quality assurance services, to implementing and optimizing Quality Management Systems (QMS).
“Whether scaling up manufacturing or embracing digital transformation, our lean project setups and experienced teams ensure compliance without compromising on efficiency.” says Van Acker. “We help pave the way for solutions to get to patients safely and rapidly.”
“We help pave the way for solutions to get to patients safely and rapidly.”
A gateway to the European market
Europe’s life sciences market is uniquely challenging, with strict regulations and evolving requirements. Whether companies are EU-based and looking to expand, or non-EU and aiming to enter Europe for the first time, the Group provides the expertise and support needed to make market entry smooth and compliant. “Our vision is to be the trusted life sciences partner guiding companies through Europe’s complex landscape with confidence,” Van Acker shares.
“Our vision is to be the trusted life sciences partner guiding companies through Europe’s complex landscape with confidence.”
QbD Group guides companies through regulatory strategy development, acts as an EU representative, supports clinical trial management, and handles post-market activities. With over 650 experts, the Group’s strong regional knowledge and trusted relationships with authorities help companies navigate hurdles to achieve their goals effectively.
QbD Group’s service portfolio
To meet the diverse needs of life sciences companies, QbD Group offers a broad range of specialized services:
- Qualification & Validation: ensuring that equipment, facilities, and processes meet quality and regulatory demands.
- Quality Assurance: tailored support including QMS development, compliance audits, batch release, and certification, both onsite and remotely.
- Toxicology: reliable toxicology services performed by EUROTOX-certified professionals with extensive industry knowledge.
- Software Solutions & Services: driving digital transformation with compliant, efficient software tailored to life sciences.
- Lab Services: GMP-compliant analytical Quality Control testing for pharmaceutical raw materials and finished products.
- Regulatory Affairs: ISO-certified expertise to secure and maintain market authorizations through customized strategies.
- Clinical: specialized CRO services focused on accelerating the development and market entry of MedTech and IVD products.
- Vigilance: comprehensive pharmacovigilance and medical device vigilance services with proprietary tools and expert teams.
Why work with QbD Group?
“What makes QbD Group unique is how we become an extension of our client’s own teams,” according to Van Acker. “We combine deep technical knowledge with a hands-on, problem-solving mindset.”
“What makes QbD Group unique is how we become an extension of our client’s own teams.”
QbD Group’s flat decision chains and direct access to senior experts ensure agility and responsiveness, allowing the Group to deliver solutions that truly fit client’s needs, whether it’s a single consulting project or full-service outsourcing.
“We believe in transparency, ownership, and going the extra mile,” says Van Acker. “For us, success means not just meeting expectations, but building long-term partnerships based on trust and shared goals. It’s about making the journey smoother and ensuring sustainable success for every product and every company we work with.”
Europe’s life sciences landscape doesn’t have to be daunting. With QbD Group as a partner, companies gain a knowledgeable, reliable, and enthusiastic ally ready to help turn innovations into success stories.
