Project management
Minimise internal resources and let our highly-educated consultants safely manage your projects to their conclusion
We focus on the details
because patient safety is of the utmost importance
We offer a wide range of compliance services
to help you ensure that you never compromise patient safety and that you are always inspection-ready.
Whether we collaborate with you regarding validation, project management, management consulting or whether we provide training within data integrity and IT compliance, we always make sure to prepare you with the most precise legislative interpretations, enabling you to generate and maintain sustained competitive advantage.
Cooperation with us allows you to always deliver the highest quality and to always ensure that you are in compliance.
Plan your company’s success in collaboration with us.
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Compliance is first and foremost about patient safety
And patient safety is primarily based on trust.
Trust that both big and small details are handled with the utmost dedication and precision.
We consider patient safety to be a very serious matter and are therefore dedicated to the details involved in validation and optimal processes in the Life Science industry.
Our employees are our greatest asset
The qualifications and values of our employees is the most important service we offer our customers. All are hand-picked for the job, regardless of how much experience they have accrued.
They are all driven to deliver a unique service of the highest quality, and they always strive to achieve full customer satisfaction through their personality and their performance.
All our senior consultants have cross-functional backgrounds combined with competencies and experience within IT, risk analysis, processes, quality assurance and compliance.
Henrik Johanning
CEO & Senior Consultant
- IT & Automation / GAMP
- Project Management
- Management Consulting
- GMP
- Regulatory Affairs
- Training
Simon Bagger
COO, Partner & Senior Consultant
- IT & Automation / GAMP
- Project Management
- GMP
- Computer System Validation
- SAFe
Charlotte Brus Mortensen
Manager & Senior Consultant
- Quality Assurance
- Deviations/CAPA
- Design Control
- GMP
- MDD/MDR
Morten Rødgaard
Manager & Senior Consultant
- Quality control
- GMP
- Auditing
- Project Management
- Deviations/CAPA
- Management
Camilla Zenisek Ladegaard
Senior Consultant
- QMS
- ISO 13485
- Audit
- GMP
- Validation
- CAPA
- Risk Management
- FSCA
- MDD & MDR
- Project Management
Nikolaos Frangoulis
Senior Consultant
- Quality control
- GMP
- IT & Automation/GAMP
- Validation
Jesper Brandt Rasmussen
Senior Consultant
- Design Control
- Test & Verification
- Data Visualization
- Project Management
- Medical Device Development
- SAS JMP
- Stakeholder management
- GMP
- Risk management
- IVDR/MDR
- Quality review and documentation
- Validation testing
- 21 CFR Part 11
- ISO 10993-1 & ISO 13485
- Equipment validation
Lise Skytte Kirkeby
Consultant
- Design Control
- GMP
- MDD/MDR
- Project Management
- Medical Device
- Computer System Validation
- Validation & Qualification
- Facilities & Equipment
Michael Holt
Senior Consultant & Quality Responsible
- IT & Automation / GAMP
- GMP
- Facilities & Equipment Validation
- Computer System Validation
Anja Sandal Grønskov
Manager & Senior Consultant
- Quality control/ Quality management
- GMP
- QMS
- Inspection readiness
- Project Management
- Stakeholder management
- Interim management
Michael Dahl Arvedsen
Consultant
- IT- og businessprocesses
- GMP
- Validation
- GAMP5
- SCRUM / AzureDevOps
- Quality control
- Digital transformation
- Test management
Rikke Urup Mortensen
Senior Consultant
- Quality Management
- Auditing
- Change Control
- Deviations
- GMP
Rasmus Kragh Sørensen
Senior Consultant
- Quality control
- GMP
- GDP
- Deviations / CAPA
- Change control
- Project Coordinating
- Tech transfer
- Process validation
- Audit
Rune Koppel
Senior Consultant
- Quality control
- GMP
- Deviations
- CAPA
- Change control
Lene Munch Nielsen
Senior Consultant
- Quality management
- Auditing
- Deviations
- GMP
- Change control
Theis Jensen
Consultant
- Project Management
- GMP
- GDP
- Medical Devices
- MDD/MDR
- Qualification & Validation
- Risk Management
- Stakeholder management
- Data visualization
- Project coordination
Theresa Helena Østergaard
Consutant
- Quality control
- GMP
- Validation
Jonas Dahl Pedersen
Senior Consultant
- IT & Automation / GAMP
- Computer System Validation
- GMP
- Project coordination
Sidsel Høgenhaug Jakobsen
Consultant
- GMP
- MDD/MDR
- Medical Devices
- Risk Management
- Quality
Lars Brandt Holst
Consultant & Project Manager
- Design Control
- Risk Management
- MDD and MDR
- GMP
- Computer System Validation
Frederik Winther Vahlgren
Consultant
- Data Integrity
- GMP
- Risk Management
- Computer System Validation
Vibeke Bach-Hansen
Senior Consultant
- Design Control
- Medical Devices
- Quality Assurance
- Non-conformances / CAPA
- MDD / MDR
- GMP/GDP
- Certified Scrum Master
- ISO 13485 QMS for Medical Devices
- 21 CFR 820.30
- ISO 14971 Risk Management
- ISO 9001
- ISO/IEC 17025
Camilla Vadmand
Senior Consultant
- Change control
- Project management
- Qualification
- Validation
- Audit
- GMP
- DV/CAPA
Tine Lykke Bank
Senior Consultant
- GMP
- Validation
- Facilities & Equipment Validation
- Project Support
Pernille Frost
Communikation & Office manager
Jonas Villumsen
Student assistant
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GOD SOMMER TIL ALLE!
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For the third consecuctive year awarded Gazelle by Børsen newspaper
Member of The Danish Chamber of Commerce since 2020 with a special focus on IT & Life Scienc
Member of IT-Branchen since 2020, Denmark's largest member organization for IT and Telecommunication companies
