Medical device QA/RA specialist company Symbioteq has acquired Key2Compliance, specialized in knowledge and information about CGMP and Quality Systems to the life science industry.
Both Symbioteq and Key2Compliance were founded in the 1990’s by Tomas Camnell and Anna Lundén, and they will both remain in the new company. The new company will take the name Key2Compliance (the parent company will continue to have the name Symbioteq Holding AB) and Jan Hellqvist will become CEO for both Key2Compliance AB and Symbioteq Holding AB.
From idea to market
The company will be focusing on bringing medical device companies from idea to market and thereafter development within five integrated business areas; Quality Assurance, Regulatory Affairs, Biological evaluation & toxicology, Education and courses, and Clinical development, describes Jan Hellqvist.
“There are few medical device or pharma companies that have not worked with us and through this acquisition and a strong organic growth we can provide an even better support to our customers,” he says.
The company has offices in Stockholm, Gothenburg and Lund.
Challenges for medtech companies
Key2Compliance will have a special focus on medical devices/medtech and Jan Hellqvist says that companies within this field are facing very large changes/transformations.
“Regulations are updated not only in the EU, within MDR and IVDR, but they are sharpened globally. This means for example a higher requirement for better documentation and data from clinical evaluations and clinical studies. We can for example help our clients with a Gap analysis, i.e. a report showing the difference between where a company is today and where it must be in order to keep and create new registrations,” says Hellqvist.
He also adds that after Corona, the world has become more global and “on line”. Most companies have paper based quality systems which makes their activities not compatible with their own quality systems. This is a hotbed for future problems, Hellqvist says, “and we are collaborating with Medos regarding implementation of a digital quality system that creates quality and compliance in a company. It also facilitates working from different locations and enables so called remote audits.”
Another problem for medtech companies is that many start too late with regulatory and clinical strategies, which means they lose both money, time and possibilities, says Hellqvist. “The products’ life cycles are shortened more and more and this requires a quick and correct journey from idea to market.”
Hopefully subsidiaries in other countries
In the upcoming 5-10 years, Jan Hellqvist says that the Key2Compliance/Symbioteq should not only have been established in Stockholm, Gothenburg and Lund, but it should also have developed subsidiaries in a couple of other countries.
“I also hope that that we will be the first company of choice for medtech and pharma companies working within combination products and competence development in Northern Europe. We aim to be a respected partner from idea to market with a competence that accelerates and improves our customers’ development,” says Hellqvist.
Image caption: Part of the Key2Compliance/Symbioteq team
