developed products for our services

We plan your validations and carry them out for you.

1 Scale-up Process Development

We develop processes for pharma and biotech (“downstream development”) to make manufacturing methods fit for daily industrial use.

We support experimental design, evaluation, and optimization with our own applications and implementation tools.

2 Process Optimization

With our proprietary system for production process optimization, you achieve fast, stable, and cost-effective manufacturing processes. Implementation is carried out with minimal downtime.

Our own simulation tools support rapid and efficient implementation.

3 Freeze- drying

We adapt your freeze-drying cycles to new equipment and implement the new parameters in your production with very few technical production runs.

Our simulations support successful implementation.

4 Polarized Light

Using our in-house development of a new visual inspection system, we identify and resolve production issues involving transparent materials (blister packaging, fill & finish).

5 Process Analytical Technology

With new sensors and improved analysis capabilities using our proprietary software and applications, you can enhance your process quality and increase throughput and value creation. We consolidate your data, process it, and present it in a clear and organized manner. Your operating staff can better identify trends and respond accordingly.

6 Process Validations

We conclude your implementation in production with a correct, GMP-compliant validation. We provide risk analysis, design of critical parameters, validation plan including all necessary reports.

7 Methods Transfer

We handle the transfer of your analytical methods in accordance with GMP requirements and your specific SOPs.

8 Quality Management

Our experts provide support for quality-related issues regarding both GMP and ISO 9001.

9 Simulations Virtual Factory

We support you with plant conversions, modifications to the manufacturing process, conversions and new builds with simulations of future processes (including a cinematic tour through the virtual building). You receive BIM-based processes and a lean-oriented production flow. Here we work with a specialized architect and a renowned lean specialist.

10 Project Management

We support you in planning and implementing projects. We create careful plans involving all stakeholders. We then turn the plans into reality and monitor the success. Our experts speak multiple languages and are familiar with very different corporate cultures. This is also why we successfully implement complex “multi-site” projects.

Our specialization is technical and technological projects with regulatory and GMP requirements.