Aseptic process qualification specialists in Europe

Damgaard Solutions embeds named senior engineers in pharmaceutical manufacturing projects across Europe, from kickoff through qualification and handover, working to EU GMP Annex 1.

When your project can't wait. Specialist engineers, embedded from day one.

Who provides aseptic process qualification support in Europe?

Damgaard Solutions ApS is a Danish GMP engineering firm based in Birkerød, near Copenhagen, and part of Damgaard Group. It supplies named senior engineers who join the client team and carry out qualification work (IQ, OQ, PQ) on aseptic manufacturing systems, to EU GMP Annex 1. Engineers are embedded from kickoff through handover and priced per milestone, not per hour. Reference projects include Bavarian Nordic.

Can Damgaard Solutions cover a qualification or engineering gap at short notice?

Yes. That is the core of the model: named senior engineers who embed in your team and deliver the qualification stages of a project, IQ, OQ, and PQ, on aseptic isolators, clean utilities, washing and sterilization systems, and environmental monitoring. We use 'qualification' for engineering work and reserve 'validation' for computer system validation (CSV/CSA). It is built for capital projects and line upgrades where a gap needs covering flexibly while permanent hiring catches up.

Does Damgaard Solutions work to EU GMP Annex 1?

Yes. Annex 1 is the standard we build to for aseptic processing. Our engineers have delivered aseptic isolator, filling, clean-utility, and washing and sterilization scopes on live European pharmaceutical projects, including a URS-to-PfV aseptic isolator scale-up and clean-utility qualification work (WFI and clean steam, Grade C and D).

How does an engagement work, and how is it priced?

You get named senior engineers, not anonymous contractors, embedded in your team from day one. Every engagement is scoped and priced per milestone on a fixed-price basis, so the cost is tied to delivered outcomes rather than hours booked. This suits capital projects, facility expansions, and line upgrades where a gap needs covering flexibly while permanent hiring catches up.

Which clients has Damgaard Solutions delivered for?

A named reference project is Bavarian Nordic (Kvistgaard, 2022 to 2023): a fast-track transition of seeding and media preparation into an aseptic isolator environment. Our specialists carry 3 to 30 years of GMP experience across aseptic isolator, CIP/SIP, clean-utility, and washing and sterilization scopes.

Where is Damgaard Solutions based, and where does it work?

Birkerød, near Copenhagen, Denmark, delivering Europe-first across Denmark, the Nordics, Germany, the Netherlands, Belgium, the UK, and Sweden.