RegSmart broadens its regulatory competence

The seeds of RegSmart Life Science were sown when the need for regulatory knowledge in life science increased. Today, the company has shifted up by broadening its competence on several levels – including in medical technology, pharmaceutical manufacturing and quality assurance.

RegSmart Life Science is a regulatory consulting company that helps companies navigate a complex and changing regulatory framework in life science. With just under two years in the industry, the company has established itself with a unique profile among other companies where RegSmart stands out with its deep and at the same time broad knowledge and experience of regulatory issues.

– RegSmart has enormous knowledge and experience. We have detailed knowledge of the regulatory, but we are also business strategic, which means that we stand out from the crowd. Our focus is to find a good balance for companies to work as efficiently as possible based on more parameters than just the regulatory, says Marie Gårdmark, CEO of RegSmart Life Science.

Tailor-made concept for companies

The consulting company acts as a helping hand for companies and researchers who lack regulatory competence and experience the regulatory issues as an obstacle in product development. By including the regulatory aspects early in the project, the path to market access can be streamlined, which RegSmart are experts at.

– All projects are different and there are rarely standard solutions to the challenges. Although regulations and standards are for everyone to read, our job is to read between the lines and put the regulatory expectations in the right context with the scientific possibilities in the individual project. The regulations are good but can easily be perceived as difficult to navigate, then we are there as a guide and tailor an approach for each project, says Marie Gårdmark.

Specialist competence in several fields

The company has recruited new cutting-edge skills to cover pharmaceutical manufacturing and the medical technology field. The recruitments mean that RegSmart is expanding and covering several areas where they previously lacked competence.

– We see that there is a great need in certain fields, based on the requests we receive. Through our new employees, we are growing as a company and can offer new services from a different angle, but still linked to the regulatory. At present, we are six people who work close to each other and have a huge knowledge bank together. We find ways forward through cooperation, says Marie Gårdmark.


RegSmart Life Science AB was formed in August 2019 and is part of the Group Center for Translational Research together with Clinical Trial Consultants, Lablytica and ClinSmart. RegSmart covers regulatory issues and has a global focus with a focus on the European and American markets. Read more about RegSmart Life Science here!

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