We plan and conduct your validations for you.
We develop processes for pharma and biotech (“downstream development”) to make manufacturing methods suitable for everyday industrial use.
We support with experimental design, evaluation and optimisation using our own applications and implementation tools.
With our own system for process optimisation in production, you receive fast, stable, and cost-effective production processes. Implementation is carried out with minimal downtime.
Our own simulation tools support fast and efficient implementation.
We adapt your freeze-drying cycles to new equipment and implement the new parameters in your manufacturing with very few technical production runs.
Our simulations support successful implementation.
With our proprietary development of a new visual inspection system, we capture production issues and resolve production issues with transparent materials (blister, fill & finish).
With new sensors and improved evaluation options using our proprietary software/applications, you will increase your process quality and boost throughput and added value. We consolidate your data, process it, and present it clearly. Your operating personnel will better recognise trends and be able to react.
We will conclude your implementation in production with correct, GMP-compliant validation. We will provide risk analysis, design of critical parameters, a validation plan, including all necessary reports.
We will carry out your analytical method transfer in accordance with GMP requirements and your specific SOPs.
Our experts support quality issues for both GMP and ISO 9001.
We support you with plant conversions, changes to the manufacturing process, refurbishments and new builds with simulations of future processes (including cinematic tours through the virtual building). You will receive BIM-based processes and a lean-oriented production flow. We work with a specialised architect and a renowned lean specialist.
We support you in the planning and implementation of projects. We create careful plans, involving all stakeholders. We then implement the plans in reality and monitor their success. Our experts speak multiple languages and are familiar with very different corporate cultures. For this reason, we also successfully implement complex “multi-site” projects.
Our specialisation is technical/technological projects with regulatory/GMP requirements.