Who are we?
About us
Consultancy with a different approach
About us
LEAN Compliance is a start-up consultancy specialising in the pharma and MedTech industry. Our approach to the regulatory world is different because we think differently.
For us, the business, the culture and the behaviour are the focus. We are able to adapt regulatory strategies and quality management systems to the needs and ambitions of the company. We include the culture and the people who will subsequently work with the processes, thereby creating sustainable solutions in which the company and its employees can grow.
If you are interested in learning more about what LEAN Compliance can do for you and your business, please contact us for a no obligation discussion.
LEAN compliance
Our focus areas
Valuable
Our advice is always based on the specific needs of each company - large or small. With an overview of the business model, a strategy is developed that ensures targeted implementation of the efforts needed to move the company in the desired direction.
Pragmatic approach
Competent and inclusive advice at eye level. We strive to find the most agile solution in close collaboration with employees and stakeholders. This ensures the compliance level is put in the right place and can be followed in practice going forward.
Involvement
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LEAN Compliance
Meet the team
Senior Consultant
Ann-Kathrine
Ann-Kathrine has a background as Senior Quality Engineer at Thermo Fisher and as QMS Manager for ConvaTec. She is a supporter with a capital S and possesses great stakeholder management skills. Her knowledge in LEAN management, QMS development and regulatory requirements enables her to deliver holistic solutions tailored to the company's needs.
Senior Consultant
Frederik
With more than 10 years of experience in the MedTech industry, Frederik has expertise in several disciplines within regulated companies.
Consultant
Aydin
Aydin has a background as a QA specialist at Agilent Technologies and Novo Nordisk. He is a knowledgeable QA in day-to-day operations with hands-on experience in facilitating, reviewing and approving CAPAs, deviations and change cases. His pragmatic approach and approachable nature have made him a respected and valued QA among employees and managers in both manufacturing and R&D.
Consultant
Anne Sofie
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Consultant
Mouritz
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Senior Consultant
Lone
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LEAN Compliance ApS
mail@leancompliance.dk
+45 60 61 20 82
CVR: 42598224