GBA Key2Compliance

Medical Equipment ManufacturingStockholm, Sweden51-200 Employees

We make complex things easier - all the way from idea to market - with focus on the Life Science industry providing complete solutions in all aspects of regulatory compliance. 
Member of GBA Group

Key2Compliance® is a full-service partner that offers complete solutions in all aspects of consultancy and training needs when it comes to:

•	Medica Device Quality Assurance: Quality system, GXP, technical files, inspections, audits, PRRC responsibility
•	Regulatory Affairs: Documentation and CE markings, FDA approvals and registrations in the rest of the world
•	Biological Evaluations and Toxicology: Biological evaluation, material documentation, recommendations, reports and more
•	Clinical Development: Clinical evaluations, prospective clinical studies, and post marketing studies
•	Pharma Quality Assurance: Pharma Quality Assurance: GCP, GVP, GMP, GDP and GLP, Quality system, audits, QA-manager etc.
•	Training and Courses: World-leading training for Life Science industry when it comes to compliance training: in-house, public, on-site, on-location, online, on-demand, printed matters, board games, online documentation library, online testing and eBooks

Key2Compliance®

Symbioteq Kvalitet AB and Key2Compliance® were founded as two independent companies 1994 and 1995. Symbioteq focused on consulting in 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.

With our strengthened offering, it is our ambition that Key2Compliance® will become the foremost partner for pharmaceutical and medical device companies, not only in Sweden but at an international level.

Key2Compliance® has offices in Stockholm, Lund, Gothenburg and Copenhagen.

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