”Our areas of expertise correspond to the requirements placed on medical devices and in vitro diagnostic products in order to achieve a CE-marking according to the regulations of MDR and IVDR, as well as to eventually achieve the much desired approval from the FDA”, says Jan Hellqvist, Key2Compliance CEO. “For our customers this means that they can either outsource an entire registration project or receive support from all our competence areas”.
One supplier for all needs
One of Key2Compliance’s greatest strengths is having comprehensive expertise, enabling them to take entire projects all the way through the QA and regulatory processes. This provides great advantages for Key2Compliance customers, especially small and medium-sized Life Science companies that are used to hiring freelancers and consultants from different companies.
“As many of our customers testify, it can be difficult to get the various freelancers and organizations to cooperate. It is better to hire a single supplier that has all the skills required. We have a great advantage in that we gather all the skills needed to take our customers’ projects to completion. It is even more important today, as the Life Science industry is changing and ever higher demands are placed on developers of medical devices as well as pharmaceuticals”, Jan Hellqvist underlines.
In the past, medical devices and medicines were classified separately, but today there are all possible combinations. The so-called combination products are becoming more and more common, and a big challenge lies in understanding the regulations that apply to each product primarily in the EU and USA This is where Key2Compliance can help. ”Few are as good at understanding the regulatory framework for combination products as we are”, Hellqvist adds.
The next big step
The latest area of competence within Key2Compliance is QA for pharmaceutical companies. This area of expertise was initiated based on a stated need of the customers, who are asking for a partner who can help them along the way towards FDA approval. This includes everything from quality systems, audits, inspection readiness and GxP.
“More and more customers are asking for support throughout the entire process. This has in turn brought on our next big step, which is to extend our presence internationally”, says Jan Hellqvist.
Key2Compliance was once exclusively located in Stockholm, but today also has offices in Gothenburg, Lund and Copenhagen. In the beginning of 2023 Key2Compliance moved offices in Gothenburg to the new life science district GoCo Office House hub. “GoCo is a vibrant center for innovation in life science, which will give us good opportunities to collaborate with partners as well as customers. We also want to offer an inspiring and pleasant work environment. We believe that GoCo provides it all”, says Jan Hellqvist.
Copenhagen is the latest addition of offices and is a first step in Key2Compliance’s internationalisation process. Hellqvist explains: “Our hope is to build a strong business internationally and we are starting with Denmark as we already have many customers there. We have good relations and we see a great development potential here. We are specifically strong in the field of training and education, and we cooperate with most of the major Danish pharmaceutical and medical device companies”.
In conclusion, Hellqvist adds: “The future looks bright and we continue our expansion. We will invest even more in internationalisation and in recruiting the right skills that will help develop our business even further. We will also gradually add more areas of competence, depending on what the customers and the market demand”.