The Situation

A technology company was emerging into the life science space with a brand-new technology that could revolutionise accessing the right patients for the right trials. The company had little experience in the R&D side of pharmaceutical and device work, no quality organisation existed and little experience with the regulatory frameworks surrounding their offerings

The Solution

DQA provided senior executive level expertise to support the organisation, formulating a quality strategy, introducing the company to the regulations and guidance in the healthcare world, including a full suite of services for validation of their software solution. 

Results

A fully compliant QMS, fully validated software solutions, meetings with leading healthcare authorities, allowing the company to place itself in the regulatory framework and to have ongoing contact with key regulators. This led to winning contracts with several key organisations in the pharmaceutical, device and contract research spaces.

DQA Advantage

Connectivity. DQA connected the company with key regulators, connected the products they had in the Artificial Intelligence World with real world scenarios, provided key advice on a ‘right sized’ QMS, and led the company through it’s first audits and assessments. A quality organisation was formalised within the company and DQA was retained to consult to the QA group post-adoption.