Case Studies.

A global software provider in the regulated life sciences sector needed an effective strategy to meet complex EU requirements. Without this strategy, there was a risk of significant delays and market access risks.

An international medtech manufacturer faced the complex challenge of obtaining FDA 510(k) clearance. Successful market entry was time-critical and strategically important for product positioning.

A medium-sized manufacturer of regulated products was confronted with critical production interruptions that required swift and targeted action. Ensuring production approval was of crucial importance.

A company from the medical technology sector that develops combination products was faced with the challenge of efficiently organizing the design transfer from development to production and overcoming regulatory hurdles.

An international pharmaceutical company for sterile products had to meet the new requirements of the Annex 1 EU GMP guidelines.

Thanks to targeted measures to reduce stock and optimize processes, the company was able to reduce its stock levels by 45% and increase customer satisfaction.

In a production facility for biochemical active ingredients, the mono-production line had reached its limits, which made comprehensive OEE optimization necessary in order to increase efficiency and make optimum use of production capacity.

Support with expertise and capacity.

Effectively prepare for government inspections.

A leading pharmaceutical manufacturer required comprehensive quality management processes to meet regulatory requirements for a new production line. Critical specifications required specific process definitions and system implementations.

Risk-based classification of suppliers and implementation of supplier qualification.

An international software provider in the regulated life sciences environment needed a robust internal audit system to monitor critical production processes in accordance with GMP guidelines and minimize regulatory risks.

Strategic transformation with a focus on continuous development. Gradual introduction of the operational excellence culture.

Maturity assessment and optimisation of the laboratory process landscape.

Digital demand forecast laboratory consumables.

Process Optimization for an Animal Health API Product Launch at a global-oriented CDMO Site.

Overall effectiveness of the supply chain.

Global demand management of health products.

Implementation of Lean Six Sigma in a pharmaceutical company with focus on sterile filling and packaging.