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About us
We make complex things easier
– all the way from idea to market
Development of medical devices and pharmaceuticals is a complex and demanding business. Since small and medium-sized companies seldom have all the necessary expertise in all aspects of product development, many have to rely on several different partners for the required specialist expertise.
Collaboration with Key2Compliance
Key2Compliance focuses on assisting companies in the Life Science area. We are a full-service partner that offers complete solutions in all aspects of our customers’ needs. Our services include Regulatory Affairs, Quality Assurance, Biological Safety and Clinical Development services exclusively for Medical Device and Pharmaceutical companies involved in development, manufacturing and beyond. The extensive programs for GMP and Quality Systems Training includes both Pharmaceuticals and Medical Device products throughout the full product life cycle.
Our 6 business areas
- Medical Device QA:
Quality system, technical files, inspections, audits, PRRC responsibility etc. - Regulatory Affairs:
Documentation and CE markings, FDA approvals and registrations in the rest of the world. - Biological Safety:
Biological evaluation, toxicology, material documentation, recommendations, reports and more. - Clinical Development:
Clinical evaluations, prospective clinical studies and post marketing studies. - Pharma QA:
Services related to GCP, GVP, GMP, GDP and GLP to ensure that you can fulfil all complex regulatory requirements - Training and Education:
World-leading training for Pharmaceutical and Medical Device companies, both in-house and public courses.QA
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!
Our co-workers
We are a rapidly growing team were everyone strives for increased patient safety and customer satisfaction. Although we work in five different business areas, most often we work in teams to help our customers with the development they need. Some of us have more than thirty years of experience from the field, while others are more recently employed. We are all careful about the quality in what we deliver, and we are proud to belong to the most competent team in the business. Together we have a passion for what we do, and we believe that we have the best job in the world.
Our core values
Competence
Reliability
Proactivity
Team Strength
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.
Customized Solutions
Key2Compliance offers complete and optimized solutions for companies working with development of medical devices including diagnostics, fillers and combination products. Thanks to our broad competence and extensive experience, we guide our customers through all stages of the process, from idea to market. It does not matter what your needs are – RA, QA, GXP, regulations, registrations, biological evaluations or clinical development – everything is within our expertise.
Training & Education
In addition, we can offer a first-class Training and Education program in Regulatory requirements, Quality systems and GMP aimed at our Pharmacutical and Medical Device clients. This makes the journey with us a learning experience, where we learn from each other and develop together during the process. Key2Compliance has all the keys required for a successful product development process.
With our strengthened offering, it is our ambition that Key2Compliance® will become the foremost partner for medical device companies and within training and courses also for pharmaceutical companies, not only in Sweden but at an international level.
Key2Compliance has offices in Stockholm, Lund, Gothenburg and Copenhagen.
