We make complex things easier
GBA Key2Compliance offers complete and optimised solutions within Regulatory compliance.
We can create processes and quality management systems that ensures the quality of your business and fully adapted to your organization. No more worries when the next audit appears.
We are experts on clinical evaluations and investigations and will tailor the solution for the client’s product based on competence and experience, working as part of the client’s team.
Our team of regulatory specialists can support and guide you through the entire regulatory process for your product, from idea to market, in exactly the way you need it and in the specific market where you want it to be.
We provide quality assurance services related to GCP, GVP, GMP, GDP and GLP to help you fulfill all complex regulatory requirements and ensure the quality of your product
We help you plan, perform, and document the biological evaluation as well as other preclinical studies or the analytical performance evaluation, with the safety of patients in mind. We also perform toxicological risk assessments.
We offer world-class training for Pharmaceutical and Medical Device companies. View our tailored program with in-house, on-demand and public courses.
Our Customers
Stories about how we support
our customers
"Navigating IVDR as a small company is tough—but the right collaboration makes all the difference."
"Thanks to thorough planning, hard work, strategic collaboration with both senior support from GBA Key2Compliance and support from our contract manufacturer, Prostatype successfully achieved IVDR certification—a major milestone for the company."
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"Thanks to thorough planning, hard work, strategic collaboration with both senior support from GBA Key2Compliance and support from our contract manufacturer, Prostatype successfully achieved IVDR certification—a major milestone for the company."
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Prostatype Genomics
”When we needed a common training in root cause analysis for personnel from both engineers, manufacturing teamleaders, purchasers and auditors we chose GBA Key2Compliance to deliver it for us.
The training was a great success, not least because the flexibility from GBA Key2Compliance to adjust the sessions for our needs, the possibility to add real-world cases to train on between the sessions as well as a truly competent and inspiring trainer/teacher. I can definitely recommend them for your next training event!”
The training was a great success, not least because the flexibility from GBA Key2Compliance to adjust the sessions for our needs, the possibility to add real-world cases to train on between the sessions as well as a truly competent and inspiring trainer/teacher. I can definitely recommend them for your next training event!”
Envirotainer Engineering AB
"During a critical period for Flexicon, we received invaluable assistance from the consulting firm Key2Compliance, as we were without a Quality Manager for three months. /.../
I highly recommend GBA Key2Compliance to any company seeking professional, hands-on assistance during periods of increased need for quality management. "
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I highly recommend GBA Key2Compliance to any company seeking professional, hands-on assistance during periods of increased need for quality management. "
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Watson-Marlow Flexicon
Want to work at GBA Key2Compliance
Picture yourself at one of the best places to work, surrounded by teams and people who challenge you, support you, and inspire you to be extraordinary. Key2Compliance offers more than a job. We offer limitless opportunities to make a difference for our customers and improve patient safety. Join us today.