G.P.B. Limited delivers Compliance Solutions for Regulatory Affairs (RA) and Quality Assurance (QA) in consulting, training and outsourcing services to the medical devices & biologics sector. Our experienced team provide expert, efficient compliance support services including advices, hands-on support and complete management services.

We work with:

1. Clinicians, inventors, research establishments, universities, who wish to complete Proof of Concept and define potential regulatory paths.

2. Designers and specification developers to identify standards and regulatory aspects pertinent to their device(s) and implement effective product development controls to meet regulation.

3. Manufacturers, packagers and distributors who wish to market new and/or change their medical devices or market in a new geographical location.

4. Our clients' sub-contractors, device inventors / licensors / licensees, designers / prototypers / manufacturers to develop and implement effective systems of control to meet contractual and regulatory requirements for global market clearance.
    

We are aware of the drivers to reduce the time from concept to delivery of the device to market. Accordingly we work with our Clients to plan and implement effective, efficient  strategies from concept, specification, design, development, design transfer, manufacturing and distribution of their devices.

Working closely with and assisting our clients attain and maintain the necessary regulatory approvals to market their devices world wide.

Providing hands-on executive and managerial RA & QA support and expertise to our Clients. Acting as our clients' internal compliance RA and QA resource to assist in product development, clinical assessment and regulatory clearance.

Delivering practical workshops and training courses to meet agreed objectives and defined outcomes.