A leading European CRO, Regulatory & Quality System consultancy for medical devices, IVDs and drug-device combination products operating in the EU and US.
We believe in quality, not quantity. What does that mean to you? For Donawa Lifescience Consulting (DLC), it means that we treat each project in a tailored fashion, to provide solutions that are adapted to the tasks that you must perform or manage.
With over 20 years’ experience in life science requirements, you can count on DLC to help you achieve not only your regulatory objectives, but also to be sensitive to your company’s business needs. After all, if companies do not meet their regulatory obligations in an efficient and cost-effective way, they are less likely to bring the products to market in the desired timescale, and may even affect the success of the company.
You have multiple challenges, milestones, and deadlines
You need effective regulatory, clinical study, and quality system strategies for reducing time to market
You need reliable support from professionals with in-depth expertise and knowledge across all phases of medical technology projects
We are senior professionals with extensive government and industry experience, who have the respect of regulatory authorities and industry, because we operate with integrity and purpose.
We are able to communicate with the highest levels of your company management, including the Managing Director or CEO, providing strategic advice or the regulatory, clinical study or quality system training that they may need. We are equally capable of communicating with operators on the shop floor, who need to understand their key roles in the quality management process.
We can work alongside you if you are responsible for the regulatory activities of your company, or if you are a quality system management representative who needs support from time to time to meet your regulatory or quality objectives.
Whether your company is an early stage, well-established or large multinational life science firm, we understand your challenges, milestones, and deadlines, and can help you meet the requirements for marketing clearance in Europe and the United States.
We can assist you in designing and implementing clinical investigations necessary to support market approval
We can help you develop an effective regulatory strategy so that your products reach the market in the shortest possible time
We can help make sure that your quality system meets European and United States requirements, with limited or more extensive hands-on support
"Provision of medical device, in vitro diagnostic device, and drug/device combination product clinical research (eRO), regulatory and quality system services for European and United States regulatory compliance, and European Union Authorized Representative services for medical device, in vitro diagnostic device and drug/device combination product manufacturers."
In December 2014, DLC was featured in a special Expo 2015 supplement in the Italian journal 'Eventi', celebrating the World Expo being held in Milan in 2015. The article, in Italian, on the services provided by DLC to medical device companies can be accessed here.