Medfiles is the perfect partner for Harmonia

“It feels safe to have the best experts in Finland at your disposal”

Harmonia Life Oy is a Finnish health product company that sells and markets health products for example in pharmacies and health and retail stores. The company scouts the world for potential product innovations which it then imports to the Finnish market. At the moment, the Harmonia product portfolio includes medical devices, several food supplements and one cosmetic product.

The co-operation with Medfiles started some five years ago, with a project regarding a cosmetic product. The product status was about to change to a CE-marked medical device, a status it already had in other markets. Harmonia knew that CE marking activities are highly regulated – and they did not have enough in-house experience. The Medfiles experts helped with managing the legal matters as well as the practical aspects of the change.

“After the successful cooperation, Harmonia decided to work with Medfiles also with food supplements,” says Sami Larste, CEO of Harmonia.

Working together on health products

Today, Harmonia consults Medfiles in various products and projects. For example, Medfiles helps Harmonia with new food supplements and legality checks of ingredients as well as with the labelling of food supplements and health claims and writing and reviewing of marketing materials.

“Whenever we launch a new product, is will at some point go through Medfiles,” says Johanna Svensk, Marketing Manager at Harmonia.

Harmonia has also received help with status changes, such as changing a CE-marked product to a cosmetic product. In addition, Medfiles has helped with the registration of a product classified as a chemical.

Convincing and wide expertise and competence

According to Svensk and Larste, cooperation with Medfiles has proven to be successful. In particular, Harmonia has been pleasantly surprised at the range of services and competence Medfiles has to offer:

“The extensive experience of Medfiles is not only limited to pharmaceuticals, but also covers food supplements and other products.”

Svensk adds that Medfiles is an excellent support especially with regulatory aspects and authority liaisons.

“The industry is highly regulated with different authority decrees, regulations and legislation. Co-operation with Medfiles creates a sense of security in what we do and lets us sleep well at night. We all have our hands full, and our core competence is not in legislative matters and details. It would be quite a task to dig out all up-to-date information, regulations and statutes and try to interpret what is allowed and what is not. Thanks to this co-operation, I can concentrate on other things.”

The Medfiles experts have convinced Svensk with the expertise.

“The experts are constantly updating their competence and keeping up to date with new changes, both in Finland and in the EU. It feels safe to have the best experts in Finland at your disposal.”

Worth its weight in gold

According to Larste, the most significant co-operation project took place in 2021, when a newly launched food supplement product was detained by the Finnish Customs, despite the careful advance preparations. One of the reasons was that a plant-based ingredient in the product is mentioned in the list of medicines, which meant that at the strictest, the product could be interpreted as a medicinal product. The Medfiles expert team helped to swiftly resolve the situation by clarifying the legislative basis and background of the product and the plant-based ingredient accurately to the authorities. Furthermore, minor challenges with the package labelling and compliant marketing communications were solved after Medfiles discussed these with the authorities.

“Without support like this, it would have been significantly more difficult to manage the situation. This a great example of the kind of support Medfiles provides for our business operations. Medfiles supports us and acts as a kind of guarantee that things are done as carefully and thoroughly as possible from the get-go,” Larste says.

For Larste, the fact that experts are quickly available and clearly know what they are doing is very valuable. Communication is active and responses prompt. Deadlines and schedules are kept every time.

“Everything works well, and it is easy to recommend Medfiles to others,” Larste says.

“For us, Medfiles has been worth its weight in gold. Our co-operation will continue in the future,” Svensk adds.