Practical PAT implementation at reasonable costs

Pharma - Modernising Manufacturing Without Compliance Risk

GMP-compliant PAT (Process Analytical Technology) implementation and process monitoring. Solid data integration for production, quality and purchasing as a basis for decision-making. With 30% reduced lead times to release. This is how they efficiently avoid data waste at reasonable costs.

We all have many years of operational experience and implement projects completely.

Project partner

SMEs and large corporations
from Switzerland and Europe

Regions and countries

Projects in Switzerland – EU – China – Japan – USA

“Hands-on management experience

MSAT & Manufacturing & Quality Supply Chain & Regulatory

Project partner

SMEs and large corporations
from Switzerland and Europe

Regions and countries

Projects in Switzerland – EU – China – Japan – USA

“Hands-on management experience

MSAT & Manufacturing & Quality Supply Chain & Regulatory

Case studies with our clients

Avoided £2 million misinvestment

Programme Management

Solid data modelling, scale up

Technically very demanding
US Corporation

-50% Costs Sterile Production PAT

Project Management

50% deeper transfer costs and a more stable production process with process design.

Problem: little data
Client: Group France

35% lower costs

Project Management 

Networked IR Camera System
pattern recognition

IT Connectivity
Customer: Pharmaceutical SMEs EU

What poor digitalisation costs

Many of these costs remain unnoticed for a long time, but they have a direct impact on costs and availability.
Problems only become apparent when projects are already delayed.

Late payment

Missing data must be obtained before the decision can be made. This leads to delays and delayed revenue.

Nerves during the quarterly discussion

Inefficient production
Small changes must be laboriously tested instead of being simulated. This costs time, money, and leads to discussions.

Unfulfilled plan figures

Poor digitalisation leads to long lead times for approval. This results in less work being invoiced.

Late payment

Missing data must be obtained before the decision can be made. This leads to delays and delayed revenue.

Nerven bei der Quartals Diskussion

Inefficient production
Small changes must be laboriously tested instead of being simulated. This costs time, money, and leads to discussions.

Unfulfilled plan figures

Poor digitalisation leads to long lead times for approval. This results in less work being invoiced.

Why data in GMP projects is often not
usable

No question of IT or software

Digitalisation projects start euphorically, but then often lose considerable momentum.

These are often the problems:

Digitalisation doesn't need giant projects but rather robust, practical, step-by-step implementation. This reduces costs and reduces risk.

6 Levers to Improve Digitalisation

We believe that practical digitalisation (outside the „buzzword sphere“) makes the difference between profit and loss.

We develop our own software along with sensors. 15% of our revenue goes into research and development.

 

Mathematical models

For swift process decisions. With our tailor-made models, we optimise validation parameters and batch sizes for cost minimisation and GMP safety.

Transparent process monitoring

The practical application of Statistical Process Control (SPC) along with systematic improvement makes the manufacturing process safe and faster.
DoE and Taguchi optimisations.

Bespoke PAT

“Process Analytical Technology” often means expensive software licences and complicated IT suppliers.

We build custom-made models, without the ballasts. With up to 30 % lower costs.

Experience

Adapt processes and workflows before actual digitisation. This ensures that business processes are future-proof for the coming years.

Our experienced team will help you implement this easily.

Avoid media breaks

Media breaks practically invite expensive rework. Delivery notes, quality certificates, batch certificates, etc. often exist in different forms.

Processes on a single channel, reducing throughput time and costs

Database maintenance

Many databases are created, but no one feels responsible for data maintenance.

Unmaintained databases create organisational duplications that cost time and money.

Databases need to be cleaned up.

Check possibilities?

Exchange of ideas

We measure our project successes

We are measuring the performance

We define goals for each project, the achievement of which we also measure. We can do this because we implement our proposals ourselves, rather than just advising. Our improvements are measurable, verifiable, and demonstrable. This is what sets us apart from large, purely consulting firms.

What do you stand to gain as a decision-maker?

We have operational management experience and technical experience. Our implementations are presentable and GMP compliant.

We specialise in implementations. We know that a technical solution must also be anchored as an administrative process, otherwise it won't work.

Here are some of the important advantages

Check possibilities?

Exchange of ideas

When our approach doesn't work

When our approach doesn't work

For our project implementation, there are prerequisites that need to align.

Escalated customer-supplier situation

Our methods are not suitable for resolving conflicts between customers and suppliers.

We can facilitate conflict resolution, but we do not conduct it ourselves.

Unstable environment

Various restructurings are already underway in parallel. Then we cannot conduct a realistic measurement of success.

We always measure success in our implementations. Once for the set project plan and budget, but we also pursue internal goals: for example, the implementation and introduction of a new technique during project execution. If too many projects are running in parallel, we can no longer measure and manage the success of our projects.

Let's have a brainstorm here.

Check possibilities?

Confidential exchange

How much will my project really cost?

When you ask this question, they've probably already had unpleasant
Experienced surprises.

Our project costs are billed based on time and effort. We provide an initial estimate of time and costs as early as the first meeting. This budget framework also works out. The overall costs are lower the faster we are allowed to be.

Cost transparency and cost control after
Project times and phases

Eoswiss Pharma compared to large consulting firms

Why do we make our projects better? We are experienced specialists in our areas of focus. Large consulting firms have neither this knowledge nor this experience.
We actively conduct our own research, keeping us at the cutting edge.

Bespoke tools for our projects

These are the processes and tools we use the most

Scale-up and process development.

Bespoke software development for tailored solutions

Development of freeze-drying cycles. Scale up & Scale down. Technology transfer of freeze-drying.

Scale-up and process development. Modelling of processes with mathematical and statistical models.

Optimisation and Process Development
Design of Experiments (DoE), optimisation of plants during ongoing production, process simulations

Process Analytical Technology (PAT)

Linking experimental data to models, using these models for process development and optimisation

Finding robust production parameters. This is where manufacturing profitability lies.

Quality Management under GMP (Pharmaceuticals, Medical Technology, Chemicals, Industry) or ISO 9001, ISO 13485

We are dealing with the optimisation of warehouses, routes, buffers for future extensions and conversions.

Our project management also includes change management. This is the only way to achieve sustainable implementation.

Without implementation, no project helps.

Technology transfer

Transfer of technologies, productions, expansion and refurbishment of facilities

Transfer Analysis

Transfer of analytical methods under GMP, including validations, verifications with all necessary documentation

Professional process optimisations (in collaboration with Japanese specialists).

Bespoke tools for our projects

These are the processes and tools we use the most

Scale-up and process development.

Bespoke software development for tailored solutions

Development of freeze-drying cycles. Scale up & Scale down. Technology transfer of freeze-drying.

Scale-up and process development. Modelling of processes with mathematical and statistical models.

Optimisation and Process Development
Design of Experiments (DoE), optimisation of plants during ongoing production, process simulations

Process Analytical Technology (PAT)

Linking experimental data to models, using these models for process development and optimisation

Finding robust production parameters. This is where manufacturing profitability lies.

Quality Management under GMP (Pharmaceuticals, Medical Technology, Chemicals, Industry) or ISO 9001, ISO 13485

We are dealing with the optimisation of warehouses, routes, buffers for future extensions and conversions.

Our project management also includes change management. This is the only way to achieve sustainable implementation.

Without implementation, no project helps.

Transfer of technologies, productions, expansion and refurbishment of facilities

Transfer of analytical methods under GMP, including validations, verifications with all necessary documentation

Professional process optimisations (in collaboration with Japanese specialists).

Check possibilities?

Confidential conversation