Case Studies.

A client needed to ensure that the global registration of its standalone software (EU Classification IIb) was completed on time, taking into account specific regulatory requirements in different countries.

A company faced the challenge of launching a new product in the US, where US FDA 510(k) market clearance was critical to market entry.

A company in the manufacturing sector was facing several high-priority issues that needed to be addressed simultaneously in order to stabilize operations and secure production release.

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.

Establish robust (e)quality management processes and systems in a pharmaceutical manufacturing facility.

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

System for effective review of internal departments.

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.