Damgaard Group is the shared name of Damgård Solutions ApS and Catalyst Reactivate ApS, with Valideringseksperterne serving Danish hospitals.
Damgaard Group is the shared name of Damgård Solutions ApS and Catalyst Reactivate ApS, based in Birkerød, near Copenhagen. Two businesses serve pharmaceutical manufacturers in Europe and beyond. Valideringseksperterne serves Danish hospitals. All three work to EU GMP Annex 1 or FSTA protocols.
The three businesses are coordinated from Birkerød, a short distance from Copenhagen. Each business runs its own market, buyers and website. The group sets what they share: EU GMP Annex 1 compliance and senior engineers on delivery.
We sell no equipment and earn nothing on resale. Specifications follow the project and the inspection it has to pass.
Clients keep the same named engineers from qualification into routine operations.
Each business has its own buyer and its own revenue model.
Named specialists embedded from project kickoff through IQ/OQ/PQ qualification. Eight GMP service lines, including aseptic isolator filling, environmental monitoring, clean utilities, pharma robotics, and washing systems. Every one is delivered with fluency in EU GMP Annex 1 and international regulatory requirements. Reference work includes Novo Nordisk Måløv 2023-24 and Bavarian Nordic Kvistgaard 2022-23.
The world's first pharmaceutical-grade H₂O₂ catalyst reactivation service for GMP cleanroom isolators. Stop replacing. Start reactivating. Every batch receives ISO 15202 ICP-OMS accredited third-party testing with zero residuals validated, plus QMS-compatible documentation with every order.
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Independent annual revalidation of autoclaves and instrument washers for Danish hospitals, following the FSTA national guidelines. We sell one thing: revalidation. No equipment, spare parts or service contracts, so the only interest is that the machines perform for hospital staff and their patients.
EU GMP Annex 1, FDA and EMA requirements applied on current projects.
Enquiries are handled confidentially. NDA available on request.
English documentation standard. Danish and additional language capability available for site documentation.
Senior leadership takes client calls directly. Reference work: Novo Nordisk Måløv and Bavarian Nordic Kvistgaard.
Damgaard Group is the shared name of Damgård Solutions ApS and Catalyst Reactivate ApS. GMP engineering and H₂O₂ catalyst reactivation for pharmaceutical manufacturers, and hospital sterilizer revalidation through Valideringseksperterne.
We support clients in achieving compliance with FDA, EMA, SFDA expectations and leading pharmacopoeias. Damgaard Group does not claim agency over regulatory approvals.