Our team of experts have helped smaller pharmaceutical companies set up and refine Quality management systems, making them more attractive to “Big Pharma”; and in turn we’ve been approached by “Big Pharma” to audit and investigate the Quality systems of smaller entities.
Medical device manufacturers have turned to us for solutions to automate operational and quality work flows, making it easier to prepare and pass audits, and in the process become more productive with the resources available. Our expertise has been called upon to perform audits of factory facilities and all aspects of the supply chain.
We’ve worked with a variety of institutes; working with engineers and architects to ensure that new designs or builds are GxP compliant. We also work with existing GxP facilities with ongoing training and validation activities. Our experience has seen research scientists become more comfortable with operating in a regulated environment.
Our expertise in addressing risk and quality processes has led to us delivering solutions that have also brought about operational efficiencies. We have demonstrated a successful track record of understanding and addressing the requirements of companies across different sectors.