Wilrijk, Belgium & Oxfordshire, UK, November 8, 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 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 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).
About EUDRAC Ltd.
EUDRAC Ltd. is a specialized regulatory affairs and pharmacovigilance consultancy company, focussed on EU and UK requirements. Core activities include guidance through orphan and pediatric procedures, clinical trial support, scientific advice, labeling (including linguistic review), and management of marketing authorization applications (MAA). Their client basis extends to companies based in the 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 500 consultants worldwide in the Netherlands, Spain, France, the UK, Switzerland, Mexico, Colombia, and the US. For more information about the QbD Group, visit https://qbdgroup.com
QbD Group offers life science 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.
- Lab Services: 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 pre-validated 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.
- Business & Communications: We offer marketing and communication services to all life science clients and strategic, tailor-made services for commercialization.