BBI’s Regulatory Support for Customers

All of our manufacturing processes are performed within the framework of the ISO 9001 and ISO13485 based quality management system, and adhere to the requirements of FDA 21 CFR part 820 quality system requirements (cGMP).  

Our aim is to maintain the highest standards of quality as well as exceptional levels of service. Risk management, validation and change control systems are applied to all products. Staff training is comprehensive and documented. Strict document and batch record controls ensure that a full history of each batch is documented and readily retrievable.

We invite our customers to carry out quality audits in which we can demonstrate the flexibility of our quality framework. 

BBI can help your products attain regulatory compliance

Our expertise in quality and regulatory requirements for in vitro diagnostic products enables us to assist customers’ with regulatory planning and provide support for compliance issues including design control, risk management, regulatory submissions, labeling, change control, regulatory inspections and contracts.

We are very experienced in effectively managing and troubleshooting situations when product quality has regulatory impacts.

When you need a clinical trial of your product

If your product needs to undergo a clinical trial, outsourcing it to BBI is a simple cost-effective solution. BBI can effectively manage your trial in most global locations delivering your results.

Certifications

Downloads

ISO13485 CMDCAS Dundee

ISO 9001/ ISO 13485 Dundee

ISO 9001 / ISO 13485 Cardiff

Contact us for more information.