Digital transformation of pharmaceutical companies
We support pharmaceutical companies in implementing complex projects in a regulated GxP environment more quickly and securely.
Speed and cost efficiency are top priorities - because we come from practical experience.
Digitalization – Robust supply chains – Technology transfer
Switzerland – EU – USA – China – Japan
for medium-sized companies and corporations
We all have many years of management practice in MSAT, QA, Manufacturing, Management
We link the data from incoming inspection QC with machine data and sensor data from production and final inspection. We act as an extension of the MSAT and production team. We contribute our experience with GMP adaptations of existing dossiers. We build our own digital models according to the most modern methods of pattern recognition (SIMCA, PCA, PCR, PLS, SPC etc). We mainly use existing data. This allows you to control production highly efficiently and avoid wasting unused data. We relocate part of the QC within production. This reduces throughput times by up to 70%. More than 20 years of experience in manufacturing, quality and a keen interest in models pays off.
Companies and the company environment change. The SOP structure should therefore be adapted every 3 - 4 years. Otherwise you lose valuable time with dusty core processes. We renew processes that have to do with technology, such as transfer from development to production, quality processes and manufacturing. We act as an extension of the QA team and bring in our experience with audits and regulatory. Our team has 23 years (average) of management experience in large mid-sized companies and corporations.
Strong supply chains are the basis of any good production. We analyze and evaluate suppliers, depending on whether they are easy or difficult to replace. We look for strategic secondary suppliers and qualify and validate them. Supply chains usually account for a high proportion of the total value added (often over 50 %), which is why we work here with our practical experience and great care. A good supplier structure is decisive in competition. It often makes sense to adjust the batch sizes and order frequency. You have a robust, flexible supply chain and thus avoid your "out of stock" risk.
We supervised the construction of two factories (in Germany and the USA), including the installation of equipment and commissioning.
„Truly outstanding! We finished four months ahead of schedule, while staying within budget! Thanks to these four extra months, we will achieve record results this year!“
Chief Operating Officer of a DAX company
Due to regulatory issues, production (sterile filling) had to be transferred within Europe as quickly as possible. The registration changes were made without any problems, based on the data and mathematical models.
„Despite the existing problems in quality and production, manufacturing was relocated within six months. And the first validation batch is fully marketable!
This secures the entire site!“
COO of a pharmaceutical company in the EU
Integration of visual monitoring (IR cameras) of production across 12 production lines. Automatic fault detection (pattern recognition, AI). Integration with process control system.
„Thank you very much! We had obtained quotes for ready-made IT systems in advance. Even without staff training, the costs would have been 65% higher than our current system, which is completely customized.“
Head of Quality; Medium-sized company EU
We relieve you and your core team for specific projects.
We minimize your regulatory risks and you have clear responsibilities and a transparent organization.
You have a highly experienced project team with a high level of technological expertise.
We relieve you and your core team for specific projects.
We bring in hands-on experience from experienced managers. We organize your projects as „low risk“ GMP projects, with maximum speed and within budget.
We minimize your regulatory risks and you have clear responsibilities and a transparent organization.
You have a highly experienced project team with a high level of technological expertise.
We are seven experienced practitioners (QA, QC, QM, manufacturing, data science, R&D, supply chain) with additional FTEs depending on the scope of the project (FTEs from 10 to approx. 40).
We simply carry out your projects.
We work in small project teams. This makes us more than efficient: we are effective.
We made our mistakes years ago.
We'll spare you that.
We stay within budget - that's important to us. We know cost pressure and pressure on results from our own experience.
We actively develop our own sensors, networking, and algorithms. This is how we apply new technologies.
If you want to do a pilot project here - let's talk!
That always interests us!
