About us

We make complex things easier

– all the way from idea to market

At Key2Compliance, we make complex things easier for Medical Device, IVD, and Pharma companies. With over 70 dedicated professionals, we offer expert consulting and specialized training.

As your trusted partner, we always prioritize your success, ensuring a smooth journey guided by expertise and customer-centric values.

Rely on Us

Key2Compliance offers complete and optimised solutions within Regulatory compliance for the Life Science industry. 

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.

About Key2Compliance ​

Symbioteq Kvalitet AB and Key2Compliance were founded as two independent companies during the 1990s. Symbioteq focused on consulting in the area of Regulatory and Quality for medical devices and Key2Compliance soon became a leading company in Training and Education in the field of Current Good Manufacturing Practice (cGMP). After several years of cooperation, the two companies merged in 2020 and formed a joint company called Key2compliance, a company within the Symbioteq group.

Key2Compliance offers comprehensive and optimized solutions in regulatory compliance. We are a full-service partner offering consulting and training for medical devices, In Vitro Diagnostics, and pharmaceutical companies. Key areas of expertise at Key2Compliance include medical device QA, pharma QA, regulatory affairs, clinical development (CRO), biological safety, as well as training and courses.

We have offices in Stockholm, Lund, Gothenburg and Copenhagen. Please find our local contact details below. 

“Our most important asset is our dedicated staff. Our team consists of specialists from all over the world, with long and broad expertise in all aspects of the development of medical devices and in vitro diagnostics. It is the team that makes the difference!​”

Jan Hellqvist,
CEO

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Locations

Stockholm (Head office)

Lund

Göteborg

Copenhagen

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