Try not to see pressure from competitors, demanding customers or regulatory requirements as insurmountable challenges. Instead, view them as opportunities to reposition your company or make disruptive changes. We will guide you on your journey towards more innovation and flexibility, work together with you to create a model for reducing costs or develop an effective time-to-market strategy that is tailored to your services and products.
Caught between regulation and new business
Digital transformation is changing society and also the needs of healthcare facilities, doctors and patients. At the same time, existing regulations and checking procedures are also undergoing changes. Do not view these challenges as hurdles. See them as opportunities to optimise your business processes. Our experts will support you. We bridge the gap between process expertise, compliance and innovations from technologies such as artificial intelligence or blockchains.
Benefit from our experience gained in the areas of research and development (R&D), clinical testing, sales and marketing consultation as well as the design and development of optimal systems in regulated and unregulated environments (including GxP, GAMP 5, CSV). We always use the very latest technologies such as artificial intelligence (AI), blockchains, open source frameworks or Microsoft. We will also assist you in your merchandise management system (securPharm or MSV3) solution development and will help you to validate these systems for GDP (Good Distribution Practice) and MDR (Medical Device Regulation).
The regulatory requirements with regard to MDR, ISO13485:2016 and other guidelines are currently increasing. At the same time, products need to be adapted even more quickly to the changing requirements of the market. As your reliable partner, we will advise you and help you to design and develop optimal solutions using cutting-edge technologies such as artificial intelligence, blockchains, open source frameworks or Microsoft – we will be there for you every step of the way. Our agile process models provide increased regulated agility in the development of products.
We will support you in all issues relating to the ‘digital laboratory’, in bioinformatics (associated with artificial intelligence), genetics/NGS (Next-Generation Sequencing), service portals and electronic health records (EHR) as well as in the area of personalised medicine. This will enable you to meet all the challenges encountered in diagnostics that are characterised by process and cost excellence plus the optimisation and improvement of laboratory system integration.
Successful projects in the Life Sciences sector
Do you have any questions?
Your contact person
Thomas Strong
Division Manage Life Sciences