Woman with blonde curly hair, reading a paper at a desk in an office, looking down with a slight smile.

Quality and Certifications

At Galena Pharma, we are dedicated to produce safe, high-quality, and effective health products. Our highest quality standards span the entire product lifecycle from development and registration to manufacturing and lifecycle management. The purpose of our quality commitment is to ensure that our clients receive comprehensive support tailored by their needs and that the products we manufacture meet the expectations of the end-users. 

Quality as an organisational culture

At the heart of Galena Pharma are dedicated and skilled people who, in their daily work, ensure the delivery of quality products and our commitment to compliance and customer trust. Our people are the foundation of our success, and their expertise and proactive mindset ensure that we consistently deliver safe and high-quality end products. We foster a culture where every employee takes ownership of continuous improvement, actively identifying opportunities to enhance processes, reduce risks, and ensure compliance.


Our organizational culture is founded on trust, transparency and innovation, which allows us to respond quickly to customer needs while maintaining the highest standards of quality and compliance. We believe that by building an open culture of trust, we strengthen our ability to be a reliable and agile partner in the healthcare industry.

eQuality Management System

eQuality Management System

The quality of our products comes from our people, and their operations are guided by our electronic quality system.


All our processes are guided by the EU GMP guidelines and adhere to internationally recognized standards, including: ISO 9001:2015, ISO 13485:2016, ISO 14001:2015, ISO 22716:2007, ISO 45001:2023, ISO 27001:2022.

We fully comply with the EU Medical Device Regulation (MDR 2017/745). As a legal manufacturer under MDR, Galena Pharma ensures that all activities, procedures, and documentation meet the highest regulatory standards.

Certifications and Permits

Industrial manufacture and packaging of pharmaceuticals
Nutritional supplements
  • Compliance with national food legislation
Cosmetics

Environmental management system

Quality management system

Continuous improvement for sustainable future

At Galena, we acknowledge the significant environmental and social challenges facing the world today.


Sustainability is integral part of our quality management system and since 2022 we have been ISO 14001 certified company. In 2025 we published our first Sustainability Report which complies with the ESG standards. We have identified the most important areas of action in our operations and are implementing measures according to the set KPIs. Galena Pharma is committed to transparency, sustainability, and long-term value creation for all stakeholders.

Quality products from the beginning to the end

Everything we do is based on quality. With years of experience and a dedicated team of professionals, we ensure that the products we manufacture meet the highest quality standards in the industry. If you want to know more about our quality principles, don’t hesitate to contact us!

News & Insights

Galena Pharma logo ja tuotteita rinnakkain

Tapaa Galena Pharma alan johtavissa verkostoitumistapahtumissa

August 18, 2025
Olemme innoissamme voidessamme ilmoittaa, että Galena Pharma osallistuu useisiin verkostoitumis- ja yhteistyötapahtumiin eri puolilla Eurooppaa vuoden 2025 jälkipuoliskolla. Tämä on loistava mahdollisuus tavata tiimimme kasvotusten, tutkia yhteistyömahdollisuuksia ja oppia lisää innovatiivisista lääkinnällisistä laitteistamme. Osallistumme seuraaviin tapahtumiin:  PharmaSynergy OTC 24.–25. syyskuuta Roomassa, tapahtumasivulle pääset tästä CPHI -messut 28.–30. lokakuuta Frankfurtissa, tapahtumasivulle pääset tästä euroPLX by RauCon 24.–25. marraskuuta Berliinissä, tapahtumasivulle pääset tästä Tietoa Galena Pharmasta Galena Pharma on GMP- ja MDR-sertifioitu lääketehdas, joka on erikoistunut ainepohjaisten lääkinnällisten laitteiden kehittämiseen ja valmistukseen. Tarjoamme valmiita, MDR-hyväksyttyjä lääkinnällisiä laitteita lisensoitavaksi private label -ratkaisuina. Keskeisiä painopistealueitamme ovat ruoansulatuskanavan terveys, naisten intiimialueen hyvinvointi, yskä ja flunssa, kivunlievitys sekä ihonhoito. Tule tapaamaan meitä ja keskustelemaan siitä, miten voimme rakentaa menestystä yhdessä! Lisätietoja ja tapaamisaikojen sopiminen: Hrvoje Pervan, Myyntijohtaja, Keski-Eurooppa hrvoje.pervan (at) galena.fi

Katarina Lundh has been appointed as Business Development Director of Galena Pharma

August 7, 2025
Katarina Lundh will start in the position on 11.8.2025. She succeeds Atte Kukkonen, who will continue working with Galena Pharma as a member of board.
Galena Pharma logo next to skincare products on a teal background.

Meet Galena Pharma at Leading Industry Events

August 5, 2025
We’re excited to announce that Galena Pharma will be attending several networking and partnering events across Europe during the second half of 2025. This is a great opportunity to connect with our team in person, explore potential collaborations, and learn more about our innovative medical devices. Join us at the following events: PharmaSynergy OTC on September 24-25 in Rome, to the event page click here CPHI on October 28-30 in Frankfurt, to the event page click here euroPLX by RauCon on November 24-25 in Berlin, to the event page click here About Galena Pharma Galena Pharma is a GMP- and MDR-certified pharmaceutical company specializing in the development and manufacturing of substance-based medical devices. We offer ready-to-market, MDR-approved medical devices available for in-licensing as a private label product. Our key focus areas include Gastrointestinal health, Female intimate care, Cough & cold, Pain relief and Skin care. Let’s meet and discuss how we can success together! More information and meeting appointments: Hrvoje Pervan, Sales Director, Central Europe hrvoje.pervan (at) galena.fi