When your project can't wait.
Named senior engineers for pharmaceutical projects, embedded in your team from kickoff through qualification and handover. Eight GMP service lines, priced per milestone.
WHAT WE DOEight disciplines, one embedded team.
We don't send advisors. We send senior engineers who stay until the job is qualified and handed over.
How we work
One fixed price per milestone, agreed before we start.
Every Damgaard Solutions engagement is built around signed, GMP-compliant deliverables and priced per milestone. You see the named CV of your specialist before anyone sets foot in your facility. That is what makes fixed-price contracting possible in regulated manufacturing.
01
Milestone packages mapped to GMP deliverables
Every project breaks into discrete phases, each closing with a signed deliverable your QA and regulatory teams can accept. IQ complete. OQ complete. URS approved. You see what you are buying before work begins.
02
Fixed price per milestone, locked before we start
No time-and-materials surprises. We set the price at project outset and tie it to delivery of each signed milestone. If scope changes, we document it and tell you what it costs before the next invoice, not after.
03
Free conceptual brief before you commit
If you are not sure whether the problem needs conceptual definition, engineering, or qualification, start here. We return a one-page diagnosis within 48 hours. It is free and commits you to nothing.
Engagement flow
How a Damgaard Solutions engagement begins
Free conceptual brief
Share your challenge on a 30-minute discovery call. Within 48 hours we return a one-page assessment: current state, the gap, our recommended route forward. No cost.
Paid meeting report
If the brief lands, we invest in scoping. We document milestones, acceptance criteria, and fixed pricing into a meeting report you can take to finance and QA before any project contract is signed. The meeting report is free in most cases. When your challenge requires outsourced inputs (such as simulation, specialist modeling, or third-party assessments), we quote the outsourced work transparently before we start.
Project contract
Milestones confirmed, acceptance criteria approved, fixed pricing locked. You pay per milestone on delivery of each documented deliverable, not per hour. We adapt to your project management style: fixed-date milestones in a waterfall approach, or dynamic milestones in an agile approach where we adjust the delivery timeline together when project evolution requires it. Either way, every change is documented and confirmed before it affects cost.
Our commitment
You meet the engineer before the engineer meets your site.
Scope creep and cost overruns in pharma projects trace back to engineers learning on your time. Damgaard Solutions does not staff that way.
Named senior specialists deliver every engagement. You meet them by CV before the engagement starts: practitioners who have run the same scope on regulated manufacturing sites and know what your QA, validation, and engineering teams need to see at every milestone.
When project team members on your side change in the middle of projects, we onboard them through a workshop so the project keeps moving.
You know exactly who is coming before anyone sets foot in your facility. That is what lets us fix the price per milestone, and what gives QA, the project lead, and finance one agreed number to plan against.
Frequently asked questions
What does "embedded from day one" mean?
It means a named senior specialist joins your project team directly and owns their scope from the start, bringing current EU GMP experience without adding permanent headcount.
What is commissioning and qualification (C&Q)?
The documented process of verifying that pharmaceutical equipment and facilities are installed and perform as intended under GMP, across installation, operational, and performance qualification (IQ, OQ, PQ).
What is the difference between IQ, OQ, and PQ?
IQ confirms correct installation, OQ confirms correct operation across the intended range, and PQ confirms reliable performance under real production conditions.
What does EU GMP Annex 1 require for isolators?
A documented Contamination Control Strategy, with isolators providing a validated barrier, continuous environmental monitoring, integrity testing, and validated bio-decontamination.
How quickly can Damgaard Solutions start?
Named specialist CVs are delivered within 48 hours, and specialists embed on your project across Europe and the Gulf.
Featured ProjectAseptic scale-up for Bavarian Nordic, Kvistgaard.
2022–2023
Bavarian Nordic
EU GMP Annex 1
Named specialists.
Not a bench.
Every engagement starts with a named CV. You know exactly who is coming and what they've delivered.
Rent time on a working aseptic isolator
A working aseptic isolator with VHP in Allerod, scoped by the assignment for VHP studies, operator training, smoke-study pre-testing, and catalyst reactivation. Run by senior engineers who have qualified isolators at Novo Nordisk and Bavarian Nordic. A written proposal in two business days.
Explore isolator rentalSend us the scope. We name the engineer.
Tell us about your project. We will tell you who to send.
