We identify and resolve bottlenecks in technology transfer, scale-up, validation, and QA.
GMP-compliant implementation strategies that shorten critical project paths for tech transfer, scale-up, and QA projects by 30-40% while ensuring full regulatory control
SMEs and corporations
from Switzerland and Europe
Projects in Switzerland – EU – China – Japan – USA
MSAT & Manufacturing & Quality Supply Chain & Regulatory
Program Management:
Construction of production buildings
High time pressure, complex logistics
15 months instead of 19 months
(Brownfield / Greenfield Project) Customer: DAX Corporation
Overall Project Management:
Emergency production transfer
Extreme time pressure
6 months instead of 18 months
Customer: Mid-sized pharmaceutical company
Program Management:
Complex coordination of new factory construction, time pressure
Customer: DAX corporation
production building
(Brownfield / Greenfield project) DAX corporation
Emergency production transfer
Pharmaceutical SMEs ; Germany
Our largest project, new factory construction for the Dax group
Unmet quarterly figures generate unnecessary discussions
Additional capacity for the delayed project slows down other activities
Additional staff, unnecessary repetitions cause unplanned additional costs
production building
(Brownfield / Greenfield project) DAX corporation
Emergency production transfer
Pharmaceutical SMEs ; Germany
Our largest project, new factory construction for the Dax group
No IT or software question
Almost never do projects get delayed because of the wrong software or insufficient IT infrastructure. It is often these problems:
If these problems are not resolved, project times and costs will double
Systems are not 1:1 comparable
Minor adjustments are necessary
Additional coordination between QA, production, and the customer is necessary.
The already long lead times for components are being exceeded
production building
(Brownfield / Greenfield project) DAX corporation
Emergency production transfer
Pharmaceutical SMEs ; Germany
Our largest project, new factory construction for the Dax group
In our experience, technical and technological obstacles are very rarely the real trouble spots of projects and processes.
There are numerous theories on project management, and they are easy to look up. Implementation is something you learn over the years. Only solid implementation brings real cost advantages.
With a few months of external support, you reorganize the projects and achieve a very fast and therefore cost-effective implementation.
External experts build on their experience. This allows processes to be targetedly improved while simultaneously reducing the GMP risk.
We perform optimizations using simulations based on measurement data and laboratory tests. This reduces costs to 10 % compared to production trials.
When SOPs no longer work, we overhaul, streamline, and simplify them. This is how a simple document change improves the economic result.
Technique and technology are coordinated with each other right from the start. This simplifies complex technology transfers and ensures they are carried out safely.
In the technical field, it is easier to measure process performance. However, it is more important in administrative processes such as quality, regulatory, and business development. Measurement is necessary in order to improve.
The total duration of a project (e.g., technology transfers) determines the total costs of the projects and business processes.
The project duration directly determines costs, revenue, and capacity utilization.
Here are some of the important benefits
For the implementation of our project, there are prerequisites that must fit.
Our methods are not suitable for resolving conflicts between customers and suppliers.
We can facilitate conflict resolution, but we do not conduct it ourselves.
Various restructurings are already running in parallel. Then we cannot carry out a realistic measurement of success.
We always measure success during our implementations. On the one hand, against the established project schedule and budget, but we also pursue internal goals: determining our own processing times and implementation times, for example. If too many parallel projects are running, we can no longer measure and control the success of our project.
Let's have an exchange of thoughts on that.
If you are asking this question, you have probably already experienced unpleasant surprises.
Our project costs are billed on a time and materials basis. During the very first conversation, we provide an initial estimate of time and costs. This budget framework holds true. The total costs are lower the faster we are allowed to be.
Cost transparency and cost control according to
Project times and sections
Why do we make our projects better? We are experienced specialists in our core areas. Large consulting firms have neither this knowledge nor this experience.
We conduct active research ourselves - so we are always up to date.
We use these processes and tools the most
We link production data and laboratory data to create meaningful tools. Improvement of raw materials, APIs, and finished products.
Development of freeze-drying cycles. Scale-up & scale-down. Technology transfer of freeze-drying processes.
Scale-up and process development. Modeling of processes using mathematical and statistical models.
Optimization and Process Development
including Design of Experiments (DoE), optimization of plants during ongoing production, and process simulations
Process Analytical Technology (PAT)
Linking experimental data to models. Use of these models for process development and optimization.
Finding robust production parameters. This is where manufacturing profitability lies.
Quality management under GMP (pharma, medical technology, chemistry, industry) or ISO 9001, ISO 13485
We are working on optimizing warehouses, transit routes, and buffers for future expansions and modifications.
Our project management also includes change management. This is the only way to achieve sustainable implementation.
Without implementation, no project helps.
Transfer of technologies, production facilities, expansion and conversion of plants
Transfer of analytical methods under GMP including validations, verifications with all necessary documents
Professional process optimizations (in cooperation with Japanese specialists).
We use these processes and tools the most
Scale-up and process development.
Custom software development for tailored solutions
Development of freeze-drying cycles. Scale-up & scale-down. Technology transfer of freeze-drying processes.
Scale-up and process development. Modeling of processes using mathematical and statistical models.
Optimization and Process Development
including Design of Experiments (DoE), optimization of plants during ongoing production, and process simulations
Process Analytical Technology (PAT)
Linking experimental data to models. Use of these models for process development and optimization.
Finding robust production parameters. This is where manufacturing profitability lies.
Quality management under GMP (pharma, medical technology, chemistry, industry) or ISO 9001, ISO 13485
We are working on optimizing warehouses, transit routes, and buffers for future expansions and modifications.
Our project management also includes change management. This is the only way to achieve sustainable implementation.
Without implementation, no project helps.
Transfer of technologies, production facilities, expansion and conversion of plants
Transfer of analytical methods under GMP including validations, verifications with all necessary documents
Professional process optimizations (in cooperation with Japanese specialists).
Pharma projects can be implemented faster if implementation bottlenecks are identified early and specifically resolved. Crucial factors are clear responsibilities, close coordination between MSAT, QA, and production, as well as active management of CDMOs. As a result, delays in technology transfer and validation can be significantly reduced.
GMP projects are frequently delayed by the overload of MSAT and QA teams, a lack of alignment between departments, and insufficient control over external partners such as CDMOs. These factors lead to delays in technology transfer, validation, and batch release while simultaneously increasing compliance risk.
GMP risks can be reduced if quality requirements are integrated into implementation from the outset. This includes close coordination between QA, MSAT, and manufacturing, as well as consistent documentation along the actual process. Early identification of deviations prevents issues during audits and inspections.
Collaboration with CDMOs is improved through clear governance structures, transparent communication, and active management of external partners. It is important that progress, risks, and responsibilities are continuously monitored to avoid delays and quality issues.
External experts are useful when projects are delayed, validations fail, or internal teams are overburdened. They help to quickly identify bottlenecks, accelerate decisions, and bring projects back under control.
Technology transfer can be accelerated by clear process definitions, early alignment between MSAT, QA, and production, as well as structured management of CDMOs. The key is to identify risks early and manage them actively rather than acting reactively.
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