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About us

We make complex things easier

– all the way from idea to market

At GBA 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.

Part of GBA Group

Part of GBA Group

As of January 16, 2024, GBA Key2Compliance is proudly part of the GBA Group. This partnership brings numerous benefits, enhancing our service offerings and expanding our global reach. GBA Group’s extensive resources and expertise allow us to provide even more comprehensive support along the entire value chain — from preclinical development and clinical trials to production release and quality assurance. 

By integrating with GBA Group, we are better equipped to ensure patient safety through optimized solutions, greater efficiency, and more effective compliance with regulatory standards, ensuring our clients receive unparalleled service and support.

Rely on Us

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

MEDICAL DEVICE QA​

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.

BIOLOGICAL SAFETY

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.

REGULATORY AFFAIRS​

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.

PHARMA QA​​

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

CLINICAL DEVELOPMENT​ - CRO

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.

TRAINING & COURSES​

We offer world-class training for Pharmaceutical and Medical Device companies. View our tailored program with in-house, on-demand and public courses.

About GBA 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.

As of January 16, 2024, GBA Key2Compliance is proudly part of the GBA Group.

GBA 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 offices
“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)

  • Skeppsbron 44
    SE-111 30 Stockholm

Lund

  • Medicon Village
    Scheeletorget 1
    SE-223 63 Lund

Göteborg

  • GoCo House
    Entreprenörsstråket 10
    SE-431 53 Mölndal

Copenhagen

  • Key2Compliance Aps
    Symbion - Fruebjergvej 3
    DK-2100 København Ø
GBA Key2Compliance
© 2020-2024 GBA Key2Compliance AB. All rights reserved.

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