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Quality is at the heart of our operations

Here at BBI Solutions, quality excellence governs all we do

Our consistent approach to manufacturing and supplying the highest quality products, ensures that we not only surpass our customer service requirements but that we also conform to all applicable regulatory requirements. Delivering these standards is the primary business KPI, within the BBI Group.

Each BBI Solutions site measures their success against this primary objective via a range of processes, these include:

  • Rigorous internal audit processes
  • Certification / notified body audits
  • Regulatory body audits
  • Customer satisfaction results
  • Customer site audits
  • Product performance evaluations

Regulatory Controls

Operating in an ever changing regulatory landscape, our BBI sites pride themselves on being market leaders, having effective change controls in place to support regulatory changes. Our position ensures that all products developed and manufactured are fit for purpose, and comply with individual country specific regulations and/or safety requirements that are applicable to our business.


At BBI Solutions we understand the importance of an effective SIPOC (Suppliers – Inputs – Process – Outputs – Customers) process and stringent controls are applied, across all of our outsourced processes.

In our aim to achieve process excellence, we ensure that all internal processes are:

  • Monitored
  • Measured
  • Effectiveness maintained
  • Continually improved

We pride ourselves on fully supporting our customers and partners, at each stage of product development - from robust design and development through to product registrations.

Our People

Rigorous recruitment, training and development of all BBI Group personnel is evident from the level of expertise within the business.

All personnel have annual objectives, which are aligned with strategic business objectives, ensuring that everyone understands the importance of surpassing customer and quality requirements. Being part of this critical process ensures that our personnel recognise and value their individual contribution, as process owners.

Quality Control & Quality Assurance

Each site follows strict Quality Control and product release protocols, which coupled with effective Quality Assurance processes ensure our products meet stringent product quality, safety and customer requirements.

Our business success, is proof of our commitment to compliance and customer service and further demonstrated by our certified Quality Management Systems.

ISO Certifications

For details of our ISO certifications for each of our manufacturing sites, please visit our ISO Certifications page.

Rann Card

The Rann card has been developed by BBI as a means to assess signal intensity of gold based lateral flow based assays. Please visit our Rann Card page.

Get in Touch…

If you have a query regarding BBI Solutions’ compliance status, please contact:

BBI Solutions Brands


The acquisition of DIARECT in June 2020 and their world leading recombinant autoimmune antigen capability immediately enhances BBI’s portfolio and position as a ‘complete’ immunoassay reagent supplier. This further enhances BBI’s position as the world’s largest diagnostics components company with a market leading antigen portfolio.


Maine Biotechnology Services brings 27 years of knowledge, experience, process development, and project management to our customers to ensure the best possible antibodies for any application. As antibody development goals in the biotechnology and pharmaceutical industry have evolved the acquisition of MBS will help BBI further meet and exceed our customers needs.


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