Tuesday November 8th 2022



The QbD Group, a privately held company offering comprehensive support to life science companies throughout the entire product lifecycle, today announced the acquisition of EUDRAC Ltd, a specialist regulatory and pharmacovigilance consultancy.

EUDRAC Ltd provides a bespoke consultancy service throughout product development, regulatory approval, market launch, and into life cycle management. Their success is built upon strong relationships with EMA and MHRA and experience across a wide range of therapeutic areas, pharmaceutical forms, and an in-depth knowledge of legislation and guidance.

Joining the QbD Group will allow EUDRAC Ltd access to a broader client base and the infrastructure necessary to ensure continued growth. EUDRAC Ltd will be renamed as QbD Ltd.

In turn, this acquisition will expand the QbD Group’s regulatory affairs division to better serve its pharmaceutical customers, including those developing advanced therapy medicinal products (ATMPs).

Carole Pugh, Managing Director of EUDRAC Ltd said: “We’re delighted to bring our expertise into the QbD group. This is the right time for us to make this step and will allow us to benefit from the synergies the acquisition will bring. In addition to bringing opportunities for business growth it will give our team of experts opportunities to broaden their knowledge and skills.”

Bart Van Acker, founder and CEO of QbD, added: “The QbD Group is continuously expanding our already broad ecosystem through strategic alliances and acquisitions. The addition of EUDRAC Ltd takes us yet another step closer to our QbDream of offering a comprehensive range of skills and expertise to support product development throughout the life sciences.”

About EUDRAC Ltd

EUDRAC Ltd is a specialised regulatory affairs and pharmacovigilance consultancy company, focussed on EU and UK requirements. Core activities include guidance through orphan and paediatric procedures, clinical trial support, scientific advice, labelling (including linguistic review) and management of marketing authorisation applications (MAA). Their client basis extends to companies based in EU, US, Switzerland, Israel and the UK.

About the QbD Group

Since 2011, QbD has been providing quality solutions for product development and manufacturing. The QbD Group’s team offers the skills and expertise for solving complex problems for companies active in the life sciences. The QbD Group is headquartered in Belgium and has over 450 consultants worldwide in the Netherlands, Spain, France, UK, Switzerland, Mexico, Colombia, and the US.

QbD Group offers life sciences companies a range of services from idea to patient within seven divisions:

  • Regulatory affairs: We help our clients in their journey throughout the entire drug and medical device regulatory lifecycle.

  • Clinical: We are an expert clinical solutions provider specialized in medical devices and biotech, offering global CRO services and consultancy.

  • Qualification and validation: We guarantee that products meet quality demands and comply with regulations through the qualification and validation of your equipment, facilities, and process support.

  • Quality assurance: We offer the full range of QA services necessary to get your product to market in a safe and compliant way, including auditing from certified auditors, setting up your QMS, and all QP (qualified person) activities.

  • Quality control: Our QC division consists of a GMP laboratory that offers analytical services for testing pharmaceutical raw materials, excipients, and release testing of finished products.

  • Software solutions & services: Our solutions include a cloud-based and prevalidated QMS built for the life sciences, as well as eIFU services which enable IVD and MD manufacturers to digitalize paper Instructions For Use. Our range of services includes computer system validation and digital health services.

  • Go-to-market: We offer marketing and communication services to all life science clients and strategic, tailor-made services for commercialization. For more information, visit our website: qbdgroup.com.