Management

Helle Rasmussen

Account manager
Søren has more than 29 years experience within the healthcare business area, he is the writer of “Valideringshåndbogen” and “Projekteringshåndbogen” and is expert within a large number of areas related to Quality and Regulatory topics for medical device development and production.
Employee Management
Quality Assurance
Regulatory Affairs
See profile and CV

Søren Lyngsø-Petersen

Senior consultant, CEO
Jonas is a self-driven yellow/red Insight profile with the ability to support your engineering needs. Jonas has a degree in Mechanical Engineering, with a speciality in mechanical construction, and a proven track record from a danish machine builder.
Data Driven
Mechanical Engineering/Design
Open minded
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Jonas Højslet

Senior Consultant
Per has a wide range of competences acquired through more than 20 years of experience from Pharma and life science projects though his work for a variety of national and international bio-tech/life science /pharmaceutical/medical device companies both early stage (new products) and late stage (mature products).
GMP
Personal
Project management
Technology
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Per Rønsholt Andresen

Co-founder, specialist, senior project manager & chairman of the boards
Bo has more than 25 years of experience in the pharmaceutical and medical device industry. Bo has spent the years working as designer, consultant and project manager in projects concerning medical devices and drug delivery systems.
Management Consulting
Mechanical Engineering/Design
Project management
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Bo Hejgaard Pedersen

Co-founder, specialist and senior project manager

Process engineering

Let our broad process expertise in pharmaceutical production benefit you.

Aseptic production
Cleaning
GMP
Quality
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Reab Jaralla

Process Engineering Consultant
Sema has more than 12 years of experience in the pharmaceutical industry. Working in Xellia with different roles from Compliance specialist, production specialist, GMP documentation specialist, Senior Aseptic processing specialist, has made Sema an experience all round profile around the aseptic processing disciplines.
GMP
Qualification & Validation
Quality
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Sema Oruc

Process Sr. Consultant
Mikael is an experienced person (>15 years) within the pharmaceutical industry who is used to working according to cGMP, working in project form with both leading, driving and being involved in projects and has experience in supporting and leading employees in production.
GMP
Project management
Qualification & Validation
Technology
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Mikael Samuelsson

Process Specialist
John is a multi-disciplined Engineer with much international experience (Switzerland, Germany, Denmark, The Netherlands, Ireland, Australia).
Documentation Generation
Programming
Technology
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John Thornton

CQV/Automation Specialist
Søren has a wide range of competences automation engineering acquired through more than 20 years of experience from Pharma and food and dairy plants. He has a lot of experience working with different process control systems from conceptual design up to handover of plant.
Functional/design
Review and evaluation
Technical Project Management
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Søren Strøm

Senior consultant/Specialist, Automation Engineer
Søren has a wide range of competences acquired through more than 20 years of experience from Pharma and life science projects and manufacturing.
GMP
Line & project execution
Personal
Technology
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Søren Wamsler Christiansen

Senior Consultant
Ann-Rikka has 18 years of experience in the pharmaceutical industry. Working in Novo Nordisk A/S at a fermentation and recovery Pilot plant with hands on operation of the equipment and also reporting.
GMP
Project management
Technology
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Ann-Rikka Søgaard

Senior process Engineer

Longinus Nwabe

Finished Products Engineering

Let us drive your project forward within assembly, label and packaging process equipment.

Chemical knowledge
Innovation and technology management
Project and portfolio management
Risk analysis and barrier creation
Stakeholder management
Unit operations
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Chris Hammerum

Finished Products Engineering Consultant
Documentation
Innovation methods
Personal
Project Management and Organizational skills
Technology
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Silla Eva Bertelsen

Finished Products Engineering Consultant
Through 5 years at university, internship and professional work, Mikhail has acquired a wide range of competences from different projects at the university and industry.
Analyzing and optimizing processes for production lines
Data analysis
Development of concepts
Problem solving for production lines
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Mikhail Vladimirovich Prokopiev

Finished Products Engineering Consultant
Nermin has a wide range of competencies related to Project Management, GMP, Process Optimization, Automation and Quality Management through his time at DTU and professional work. Based on previous experience, he is a service-minded individual that prioritize the needs and satisfaction of customers in his work and strive to provide high-quality solutions.
Data Driven
Personal
Technology
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Nermin Fejzic

Finished Products Engineering Consultant
With customer service and an understanding of manufacturing, Linus systematically finds the solution between man and technology. His open mindset and stakeholder management are used to create maintain and evolve relations. Relations he used technological knowledge to create SOP, which lifts quality and is intuitive.
GMP
Personal
Project management
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Linus Knoop

Finished Products Engineering Consultant
Torben has +20 years of experience in the pharmaceutical industry with focus on project management and validation of several inspection and assembly lines as well as packaging lines for the Packaging of Finished Goods.
Performing commissioning/validation tests.
Project management
Writing commissioning/validation documentation
Writing URS
See profile and CV

Torben Jensen

Specialist and senior project manager
Filip has acquired knowledge of general theoretical knowledge within the life-science industry as a hard-working student and student assistant for several years. He has further developed an interest and flair for the use and understanding of pharmaceutical industrial tools, where he has been through several independent and team-based projects
GMP
Personal
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Filip Novovic

Finished Products Engineering Consultant
Per has a wide range of competences acquired through more than 20 years of experience from Pharma and life science projects though his work for a variety of national and international bio-tech/life science /pharmaceutical/medical device companies both early stage (new products) and late stage (mature products).
GMP
Personal
Project management
Technology
See profile and CV

Per Rønsholt Andresen

Co-founder, specialist, senior project manager & chairman of the boards
Palle has more than 13 years of experience within automation engineering of machinery in life science projects.
Automation strategies
GMP
L-AUS
Technology
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Palle Jørgin

Senior consultant, Automation engineering
Martin has through his studies and professional work acquired a wide range of competences and knowledge within user-centred design, project management, digitalization, sustainability and a variation of different product development processes.
Communication
Design Thinking
Product Development
Project management
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Martin Muncanovic

Finished Products Engineering Consultant
Klaus has a wide range of competences acquired through more than 20 years of experience from Pharma and life science projects. He is an experienced author of most document deliverables within the finished product disciplines: Assembly, Packaging and Plastic injection moulding, and is also well experienced in design-for‐manufacture of components for plastic injection moulding.
GMP
Personal
Project management
Technology
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Klaus Pedersen

Senior Consultant
Since 1996 Klaus has been working with many aspects regarding special designed assembly and packaging equipment within pharmaceutical and medical device production.
QMS Systems
Validation of packaging and assembly equipment
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Klaus Kildebæk Rasmussen

Senior Consultant
Helene is a passionate engineer with competencies within project management, documentation, and Good Manufacturing Practice (GMP). She has worked on projects spanning from sterile production and assay design to protocol optimization and chemical analysis.
 Good Manufacturing Practice
Personal
Project management
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Helene Cecilie Kiilerich Frederiksen

Finished Products Engineering Consultant

Jonas Christensen

Medical device

Let us be your experienced partner in medical device and regulatory affairs.

Anja has a wide range of competences acquired through more than 20 years of work experience from the Healthcare Sector within clinical- and quality work, risk management, project management and leading experience. She has taken roles as a midwife, obstetric sonographer, project manager and consultant in various implementing projects and latest as head of function in a regional quality department.
Line & project execution
Personal
Technology
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Anja Manby Kramper

Senior consultant
Very strong analytical skills and a solid scientific background as M.Sc. in chemical engineering and Ph.D. in biophysical chemistry. Broad experience with medical devices acquired through more than 20 years in many different roles in the medical device and pharma industries.
Project management
QA/RA
Technical insight
See profile and CV

Mads Christian Sabra

Senior Consultant
Søren has more than 29 years experience within the healthcare business area, he is the writer of “Valideringshåndbogen” and “Projekteringshåndbogen” and is expert within a large number of areas related to Quality and Regulatory topics for medical device development and production.
Employee Management
Quality Assurance
Regulatory Affairs
See profile and CV

Søren Lyngsø-Petersen

Senior consultant, CEO
Simon has more than 20 years of experience working in the pharmaceutical and medical device industry in positions as Specialist, Manager and Project Manager.
Documentation
GMP
Project management
See profile and CV

Simon Bjørn Larsen

Senior Consultant
Pavla has a wide range of competences acquired through more than 30 years of experience from Medical equipment and Medical device industry within sales, marketing, medical application training, education of end-users, and project management of industrial sterilization of medical devices.
Medical fields knowledge
Personal
Technology
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Pavla Frey

Senior consultant
Keld has a wide range of competences acquired through more than 35 years of experience from Product development, electronics engineering in life science projects and in the renewable energy sector. He has taken roles as VP electronics, R&D Manager, QA Manager, Team lead, project manager, senior electronics designer.
Compliance
Engineering
Management
Personal
See profile and CV

Keld Schmidt

Senior consultant

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