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Development of medical devices and pharmaceuticals is a complex and demanding business. Since small and medium-sized companies seldom have all the necessary expertise in all aspects of product development, many have to rely on several different partners for the required specialist expertise.

Main services by Key2Compliance

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Quality Assurance

  • Quality system

  • GXP

  • Technical files

  • Inspections

  • Audits 

  • PRRC responsibility

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Biological Evaluations and Toxicology

  • Biological evaluation 

  • Material documentation 

  • Recommendations

  • Reports 

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Training and Education

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Regulatory Affairs

  • Documentation and CE markings

  • FDA approvals and registrations in the rest of the world.

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Clinical Development

  • Clinical evaluations 

  • Prospective clinical studies

  • Post marketing studies

World-leading training for Pharmaceutical and Medical Device companies, both in-house and public courses.


Key2Compliance + Hoodin 
Key2Compliance and Hoodin are perfect partners where we share the ambition in delivering high-quality services and creating clear value for companies in life science, and we also share a clear focus on growth and that new technology can create competitive advantages.

How Hoodin and Key2Compliance collaborate

Together with Key2Compliance, we see good opportunities to continue to grow in the Nordic market with their extremely competent staff, active marketing and clear goals of becoming one of the Nordic region's largest service companies in life science.

Get in touch with Key2Compliance

"We are located in Stockholm, Lund and Gothenburg. Please find our local contact details at our website. Feel free to use our contact form to make sure we get your message, or drop us a line on LinkedIn.”

All the best, Key2Compliance

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