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Quality Management

In today’s LifeScience industry, companies face numerous challenges. Firms in the pharmaceutical, medical device, and other LifeScience sectors are bound by strict and complex regulatory requirements. QMS systems ensure that products are safe, effective and compliant. However, as demands and expectations continuously rise, many companies seek innovative solutions to maintain and improve their quality standards.

Challenges in Quality Management

Regulatory Requirements: Regulatory requirements are complex, stringent, and constantly evolving, presenting companies with the task of continuously meeting the latest regulations and standards to avoid financial, legal, and reputational damage.

Technological Developments: With the introduction of new technologies and digital tools, companies must continually adapt and improve their QMS to ensure ongoing enhancement.

Globalization: Global expansion and collaboration bring additional challenges, such as harmonizing quality standards and business processes across different regions.

Trends and Developments

A growing trend is the outsourcing of "Quality as a Service" (QaaS) to external providers and experts. This allows companies to benefit from specialized expertise without having to build extensive internal resources. External experts offer flexible and scalable solutions tailored to the specific needs and challenges of the companies.


To illustrate the benefits of external quality expertise, we present examples that highlight specific challenges and solutions in quality management:

  • QMS Implementation and Improvement: A leading pharmaceutical company successfully implemented a robust, digitally supported QMS, resulting in increased product quality and more efficient resource utilization.
  • Process Optimization: A MedTech company optimized its production processes (including compliance requirements), leading to significant cost savings, improved product quality, and competitive advantages.
  • Audit Management (Planning, Execution & Implementation): 
    • Audit Preparation: An international LifeScience company needed support in preparing for an audit. By identifying and addressing weaknesses, compliance was ensured, market access was secured, and stakeholder trust was strengthened.
    • Audit Follow-Up: A pharmaceutical company received a significant deviation (Data Integrity - Record Management) in an FDA inspection across multiple processes and departments that were not interconnected. The deviation was resolved promptly, and the processes were efficiently improved.
  • Interim Management to Bridge a Vacant Key Position: A LifeScience company required short-term external support (e.g., Head of QM / QA / QC; Qualified Person (QP, PRRC)). The deployment of an experienced interim manager ensured smooth operations until the position was filled.

Let us elevate the quality of your processes and products to the next level together!

Quality Management

How to engage with us

Some of our clients seek informal exchange with experts. Come to one of our events, where we talk about trends in the healthcare industry. Other clients simply want to get a second opinion on a difficult question. At a Sounding Board, we bring together the right experts and take a position on your question. Very pragmatically and without a large consulting fee. Sometimes, however, it is also a matter of clarifying a question. Often a tailor-made workshop with the right people involved helps to create a concrete project plan. And if you already have the plan for your project, we can help you find the right consultant or the perfectly coordinated project team. Often we also fill roles ad interim. And always without overhead costs. Because we are not a consulting firm but a network of independent entrepreneurs. And we think just as entrepreneurially as our clients.

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