Our vision for Life Sciences
Our approach starts with compliance to regulations, followed by process improvement, using quality by design principles.
A different approach, embedding QbD with a focus on regulatory compliance and efficiency optimization
We care about improving patient safety and process sustainability as much as you do, which motivates us to help record contextualized data and control processes, in compliance with regulations.
With over 50+ years¿ experience in the life sciences, we understand the challenges of working witin a regulatory framework and the importance of a modular science-based approach.
Focused on key applications and following Quality by Design (QbD) principles, we continue to invest in the development of digital engineered solutions (DES) to help reduce capital project execution costs, risks and time to market, as well as offering services tat help lower operational expenditure.
Sustainability id part of our culture, therfore our solutions are designed with this in mind, to help eliminate process waste and meet your carbon neutrality goals.
Discover key updates of EudraLex GMP guidelines, Annex 1
Discover key updates of ISPE GAMP 5 Second Edition
Laboratories and R&D plants
We know that developing compliant processes for producing pioneering drugs and targeting new diseases is costly and time-consuming.
That's why we embed quality by design in pharmaceutical development into out process development phases. Through Plug-and-Produce modular solutions, we help to assemble contextualized data to generate exception reports and provide "prior knowledge" to feed lab, plant and enterprise dashboards.
Greenfield API facilities (large and small molecule)
For those responsible for the quality and efficiency of GMP compliant plants, keeping up to date with and applying regulations is often overwhelming.
Our digital engineered solutions follow the Quality Lifecycle suggested by ICH Q8: Identify Critical Process Parameters, Risk Management, Good Engineering Practice (GEP) and Qualification. The documentation can be provided in paperless format though and SaaS platform
Brownfield API facilities (large and small molecules)
Existing manufacturing plants need to implement continuous improvement to maintain competitiveness, but we recognize that this can be difficult in validated environments.
Our understanding of how to navigate validation constraints and manage changes with minimal impact is helping customers to realize their desired process efficiency and to remove segregated (siloed) data collection.
Fill and finish (secondary pharma)
Patient centricity trends include producing personalized drugs for individual patients but following this path requires a complete transformation of manufacturing principles.
We track the life science trends closely to enable customers to adapt quickly to innovate concepts, for example: modular processing, single use systems, continuous vs batch processes, cold chain management, etc. Our technology offers easy connectivity at edge level aiding the creation of decentralized, interoperable systems.
Utilities
With consumers raising concerns about energy and resource utilization, and waste and emissions generation, how can you improve sustainability and your carbon footprint?
Eurotherm is committed to empowering all to make the most of our energy and resources. We apply GEP and help meet GMPs, but our digital engineered solutions prioritize environmental impact reduction over project execution profitability.