Delivering solutions

Have your compliance ensured

We take care of your topics around quality management

and regulatory questions

Designing smart processes

Integrate our applied manufacturing and management expertise

to improve your business

Strategic Quality Management

Connect quality and economic feasibility

to create a commercially interesting solution

Our Key Industry Focus

Medical Device

A steep increase in regulations has shaped the quality landscape in the past years. Compliance has never been so complex and costly. Assure market access with the European Medical Device Regulation (MDR) and assure your readiness for MDSAP (Medical Device Single Audit Program).

Combination Products

Technology is progressing quickly. Novel and innovative products require a more integrated approach to process development. Ensure sustainable control and compliance for your processes.

Pharmaceuticals

Complex processes within a highly regulated environment make it increasingly difficult to implement improvement. Reach your project objectives and optimize your quality systems.

What we do best

  • Swift Understanding and agility

    Long-term engagement and hands-on experience enables us to quickly grasp your situation and propose relevant and realistic measures.

  • Team Integration

    We understand the integration and promotion of your team as an essential part of our success.

  • Sustainable Implementation

    Your long-term benefit of our work is a crucial part of our motivation.

Our in-depth understanding of the normative requirements combined with a potent business excellence tool set enables us to provide a tailor-made service for a commercially sustainable quality design.

Meet the team

Our Customers

Start up

Start up

“Ensure compliance for your leap”

  • Quality system setup
  • Lead to ISO9001 and ISO13485 certification
  • Contact for all quality related topics

Medium size company

Medium size company

“Healthy and sustainable growth”

  • Interim management
  • Market access
  • Strategic support
  • MDSAP
  • MDR readiness

Large enterprise

Large enterprise

“Get ready for the future”

  • Project management
  • Improvement projects
  • MDSAP readiness
  • MDR readiness

Areas of Interest

Get in Touch

We are looking forward to meeting you and discussing your questions.

Contact us
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