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 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.
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 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.
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
“GBA Key2Compliance is our main consultant in the clinical development process. They assist in developing the clinical strategy for our product portfolio, manage details in the specific study design, develops clinical investigation plans, and of course provides general clinical regulatory advice. All in all, they project manage all our clinical investigations from start to finish”
READ MORE >
READ MORE >
Regulatory Affairs at BOHUS
"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. "
READ MORE >
I highly recommend GBA Key2Compliance to any company seeking professional, hands-on assistance during periods of increased need for quality management. "
READ MORE >
Watson-Marlow Flexicon
Previous
Next
Latest Webinars
We love to share our knowledge. Enjoy our webinar library to get the latest insights and expert knowledge.
Presented by: Åsa Möllby, GBA Key2Compliance and Ella Wilhemsson, Medos
Tags: Medical Device QA
Presented by: Winta Woldai, GBA Key2Compliance
Tags: Biological Safety
Presented by: Maria Lindgren, GBA Key2Compliance
Tags: Clinical evaluation
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.
