QbD IVD | Qarad brings 35 years of expertise in Regulatory Affairs and Quality Assurance regarding In Vitro Diagnostic Devices – which is regulated by the specific IVD Regulation (IVDR) – to the group. Its activities consist of consultancy and other services regarding CE Marking and Quality Systems and Electronic Instructions for Use.

Quercus is a GMP certified contract laboratory.Our customers are pharmaceutical companies, and other life science and health industries, such as companies involved in cosmetics, herbal products, food supplements or medical devices.

Scilife, previously called QualityKick, is a Software as a Service (SaaS) solution for companies in the Pharma, Biotech and Medical Devices sectors to efficiently manage everything quality, process and product related, always according to the relevant compliance regulations.

SIMABSis a contract development and manufacturing organisation formonoclonal antibodies. We deliver fast, flexible and cost-effective total solutions for your development and manufacturing by means of a new and unique manufacturing platform based on continuous bioprocessing.

Antleron wants to improve healthcare to ensure a better life for everyone. This innovative engineering company combines the potential of cells, biomaterials, biologics, 3D printing and bioreactors. As a result, it accelerates products, processes and technology in the life sciences industry.

SciencePharma is a Polish company offering consulting and importing services for the pharmaceutical industry. Established in 2004, SciencePharma is a leader among Polish and foreign consulting companies, having successfully implemented national and international projects.

Over the past decade, SciencePharma has prepared over 820 dossiers for medicinal products and excels in drug development projects, importation, and GMP/GDP compliance. With a diverse and experienced team, SciencePharma provides holistic support from early-stage development through clinical trials and product lifecycle management.

In 2024, SciencePharma’s team of 120 specialists joined QbD Group, further strengthening its core competencies in regulatory compliance, CMC services, and product development support. 

The Blue Mountain Regulatory Asset Manager® (Blue Mountain RAM) platform, designed exclusively for the Life Sciences industry, provides a fully validated out-of-the-box, cloud-based EAM solution combining equipment maintenance, calibration, and qualification features in a single, integrated package.

Our platform is best-in-class for asset maintenance and parts management, automated workflows, electronic signatures, powerful reporting, and robust audit trails to ensure GMP compliance across all sectors of the industry.  Blue Mountain RAM is highly configurable to meet your needs, supported by a strong technical team with many years of diverse industry experience.

Timeseer.AI is a growing top solution provider for data quality optimization. Their platform harnesses the power of advanced artificial intelligence to detect, prioritize, and investigate sensor data quality issues. This way, the experts can notify possible issues before these significantly impact operations or critical decisions.

PILS – also known as ‘Partners in Life Sciences’ – is a new partnership between Flemish companies that offer services and products in life sciences. PILS’ ambition is to improve the footprint of smaller companies towards big pharma. 

ISPE, the International Society for Pharmaceutical Engineering, is the world’s largest non-profit association that serves its members with leading scientific, technical and regulatory advancement throughout the entire pharmaceutical lifecycle. QbD’s CEO Bart Van Acker is Vice President of ISPE Belgium.

Flanders.bio is the networking organisation for the life sciences sector in Flanders. It’s a dynamic, non-profit, free-based organisation with currently more than 300 members. Bart Van Acker is a member of the board at Flanders.bio. Since the beginning of 2019, QbD set up a strategic partnership with Flanders.bio.

Amelior helps companies set up efficient management systems by means of training, advice and assistance.It specialises in quality, safety and well-being at work, logistics and production. QbD provides Amelior training programmes for GAMP 5® (ISPE), GLP and GMP in the (bio-)pharmaceutical industry.

HollandBIO is a fast-growing, privately funded interest group that represents the Dutch biotech industry. It unites various stakeholders throughout the sector: from start-ups and small to medium-sized enterprises to large companies – all of them active in health, nutrition or bio-based economy. HollandBIO’s activities include advocacy, organising networking activities, various member services and PR.

With the support of the European Union and the Flemish Government, the European Social Fund (ESF) invests in job opportunities and quality careers. Thanks to their support, QbD works on two projects to help employees develop their talents.

QbD is a partner of pharma.be, the federation of the innovative biopharmaceutical industry in Belgium, represents over 130 companies and 35.000 employees active in human healthcare in Belgium.

As a full partner of physicians, pharmacists, hospitals, governments and other stakeholders, pharma.be has the mission to promote better health care through therapeutic innovation in the domain of medicinal products for human and veterinary use. 

Healixia is the Belgian community of all professionals active along the life cycle of medicines, medical devices, IVD & other health related products. 

The BioWin competitiveness cluster brings together all the innovation system players in the field of health (biopharma and medtech) in Wallonia, with the goal of stimulating regional economic redeployment.

TOPRA is a professional membership organization for individuals working in healthcare regulatory affairs. We work with our members internationally to enable and promote excellence across the healthcare regulatory profession.

The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of professionals involved with regulatory and quality for healthcare products, including medical devices, pharmaceuticals and biologics, diagnostics, and digital health.

Founded in 1976 as a neutral, nonprofit organization, RAPS supports and elevates the regulatory profession with education and training, professional standards, publications, research, networking, career development, and other valuable resources.

RAPS is home to the Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognize regulatory excellence. The society is headquartered in suburban Washington, D.C., with chapters and affiliates worldwide.

BIVDA is the national industry association for the manufacturers and distributors of IVD products in the UK,currently representing more than 95% of the industry and over two hundred organizations ranging from British startup companies to UK subsidiaries of multinational corporations.

Canifarma represents 190 laboratories, divided into three industrial branches: Medicines for human use, Medicines for veterinary use, and Medical devices.

TEAM-PRRC is the non-profit European Association dedicated to the new profession of “Person responsible for regulatory compliance” (PRRC). The Association was created to represent and help PRRCs to more confidently assume this new profession which has considerable responsibilities in the design, manufacture, and supply of medical devices and in vitro diagnostic devices.

EMWA is the European Medical Writers Association,a network of professionals representing, supporting, and training medical communicators. It is a not-for-profit organization run for its members by its members.

The European Association of Authorised Representatives (EAAR) was established in 2002 in order to accurately represent organizations that provide European Authorised Representative services to non-European manufacturers of medical devices and in-vitro diagnostic medical devices.

Its purpose is also to maintain a dialogue with the European Commission, Competent Authorities, Notified Bodies and other European industry associations about the role of Authorised Representatives in the context of compliance with European medical device regulatory requirements.

The UK Responsible Person Association (UKRPA) is an alliance of providers of services as UK Responsible Persons as defined in the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) who have joined forces to promote professional conduct and competence.

BeCRO is a professional non-profit association of Belgian Contract Research Organisations (CROs) which are supporting the pharmaceutical, biotechnology and medical devices industry in clinical research and development of new products. The result of the combined industry efforts, including BeCRO members, is the availability of new treatments and therapies from which patients can benefit.