When your project can't wait.

Specialist pharma engineers, embedded from day one. We work across aseptic filling, environmental monitoring, clean utilities, robotics, and water and steam systems.

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COMPANIES WE HAVE WORKED WITH
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—WHAT WE DO

Eight disciplines, one embedded team.

We don't send advisors. We send senior engineers who stay until the job is qualified and handed over.

Aseptic isolator with white gloves attached, used for sterile pharmaceutical filling, with a reflection of a person working on a computer behind the glass.
Aseptic

Aseptic Isolator Filling

EU GMP Annex 1 design, qualification, and RABS/isolator integration.
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Aseptic isolator with white gloves attached, used for sterile pharmaceutical filling, with a reflection of a person working on a computer behind the glass.
Utilities

Clean Utilities

WFI, purified water, and clean steam systems. designed and qualified.
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Aseptic isolator with white gloves attached, used for sterile pharmaceutical filling, with a reflection of a person working on a computer behind the glass.
Monitoring

Environmental Monitoring

EM programme design, risk-based sampling, and GMP-compliant reporting.

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Aseptic isolator with white gloves attached, used for sterile pharmaceutical filling, with a reflection of a person working on a computer behind the glass.
Data

Pharma 4.0

Digital maturity, data integrity, and fill-finish integration. PAT, digital twin, and validation in one engagement.

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Aseptic isolator with white gloves attached, used for sterile pharmaceutical filling, with a reflection of a person working on a computer behind the glass.
Delivery

Project Management

Cross-functional leadership for CapEx builds, tech transfers, and facility expansions.

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Aseptic isolator with white gloves attached, used for sterile pharmaceutical filling, with a reflection of a person working on a computer behind the glass.
Development

R & D Engineering

Early-stage process engineering from pilot to commercial. DIY Engineering frameworks your team takes forward.

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Aseptic isolator with white gloves attached, used for sterile pharmaceutical filling, with a reflection of a person working on a computer behind the glass.
Automation

Robotics & Automation

SCADA, PLC, and CSV/CSA. integrated from engineering through validation.
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Aseptic isolator with white gloves attached, used for sterile pharmaceutical filling, with a reflection of a person working on a computer behind the glass.
Infrastructure

Water & Steam Systems

From concept design through IQ/OQ/PQ. compliant, documented, and ready.

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— How we work

Fixed-price milestones. Named senior engineers, embedded. No surprises.

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

Not sure whether your challenge needs conceptual definition, engineering, or qualification? We listen, assess, and return a one-page diagnosis within 48 hours. No cost. No commitment. Just a clearer view of what is in front of you.

— Engagement flow

How a Damgaard Solutions engagement begins

Step 01

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.

Step 02

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.

Step 03

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

Named senior engineers, embedded from day one. That is the commitment.

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 makes fixed-price milestone contracting work in regulated manufacturing, and what lets your QA team, your project lead, and your finance team all sleep at night.

— Get started

Have a project that can't wait?

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Aerial view of a large industrial or research facility with multiple buildings, parking lots, and green trees surrounding the area, featuring a Danish flag on a flagpole.
—Featured Project

Aseptic scale-up for Bavarian Nordic, Kvistgaard.

A fast-track project to transition seeding and media preparation into an aseptic isolator environment. Kasper led the full scope from durability study and URS through engineering spec, DQ, FAT, and SAT ensuring GMP and ANNEX 1 compliance without compromising timelines or budget.

2022–2023

Project Timeline

Bavarian Nordic

Client

EU GMP Annex 1

Compliance standard
See the full caseCASE STUDIES
THE TEAM

Named specialists.
Not a bench.

Every engagement starts with a named CV. You know exactly who is coming and what they've delivered.

Kasper Carlsen
LEAD ENGINEER · ASEPTIC SYSTEMS
IsolatorAnnex 1IQ/OQ/PQ
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Damgaard Solutions cleanroom aseptic isolator available for rental in Allerod, Denmark
Isolator Rental

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 rental

Ready to get started?
So are we.

Tell us about your project. We will tell you who to send.

Request a free briefMeet the specialists