Damgaard Solutions

What Damgaard Solutions does

Damgaard Solutions is a privately held Danish GMP engineering consultancy founded in 2015 and headquartered in Birkerød, Denmark. The company delivers embedded senior engineering specialists to pharmaceutical manufacturers for regulated production projects, covering eight core disciplines: aseptic isolator filling, clean utilities, environmental monitoring, CIP/SIP, pharma robotics, project management, R&D engineering, and washing and sterilization. It supplements these core services with specialized offerings including aseptic isolator rental at its Allerod facility with VHP decontamination, ISO 14937-validated ozone-based low-temperature sterilization, hospital sterilizer revalidation agreements, and CSSD planning for hospital sterile services departments. Underlying technology centers on human GMP expertise, EU GMP Annex 1 and SFDA-aligned compliance methodology, and a small set of tangible specialized assets (the Allerod isolator and ozone sterilization capability) rather than a software or data platform.

The firm's business model is built around fixed-price milestone contracts tied to signed GMP-compliant deliverables, with nine named senior specialists (150+ combined years of experience) embedded from day one through handover. The engagement funnel starts at a free 30-minute discovery call followed by a 48-hour one-page conceptual brief, then moves to a paid milestone-locked contract or a free meeting report when no outsourced inputs are required. Revenue streams combine outcome-based milestone billing on engineering projects, annual subscription-style per-unit pricing for hospital revalidation, and per-assignment unit pricing for isolator rental and ozone sterilization contracts. There is no time-and-materials billing and no retainer model.

Damgaard serves enterprise pharmaceutical manufacturers across Scandinavia and Europe (Denmark, Norway, Sweden, Finland, Germany, the Netherlands, with a Saudi Arabia footprint), with named reference customers including Novo Nordisk, Bavarian Nordic, GE Healthcare, Bayer, LEO Pharma, Lundbeck, Merck, MediCult, and Oxymat. The company is founder-owned (Kasper Carlsen as Founder and Lead Engineer), has not raised external funding, and as of 2025 has begun positioning itself around Pharma 4.0 and digital transformation as an adjacent layer to its core GMP engineering practice.

Name

Damgaard Solutions

Legal name

Damgaard Solutions ApS

Website

https://damgaard-solutions.com

Company type

Private

Founded year

2015

Operating status

Operating

Headcount range

11–50 employees

Short description

Damgaard Solutions is a Danish GMP engineering consultancy that embeds named senior specialists in pharmaceutical manufacturing and hospital projects across Europe, delivering fixed-price milestone engagements in aseptic filling, clean utilities, environmental monitoring, robotics, and qualification services.

Ownership category

akta.pro rank

Product category

Pharmaceutical GMP engineering services

NAICS

Engineering Services (541330)

SIC

Services-Engineering Services (8711)

akta.pro primary industry

Quality Engineering & Risk Management (ICH Q9/Q10, validation, change control) (HLAGAKAL)

akta.pro secondary industry

GMP Quality, Validation & Regulatory Support (GMP/CSV/Qualification) (HLAGAGAL)

Keywords

• GMP engineering services
• Pharmaceutical validation
• Aseptic filling qualification
• Clean utilities design
• Environmental monitoring

Headquarters

HQ city

Birkerød

HQ country

Denmark

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Technology or R&D, Infrastructure

Revenue model

1. Engineering services project fees: Fixed-price milestone contracts for GMP engineering engagements. Each project is scoped with discrete phases, each closing with a signed GMP-compliant deliverable. Clients pay per milestone on delivery of documented deliverable, not per hour. No retainers, no time-and-materials.
2. Isolator rental services: Rental of a working aseptic isolator in Allerod, Denmark, scoped as written proposals per assignment. Ten specialist services including VHP studies, BioTrak interference testing, operator training, smoke study pre-testing, catalyst reactivation. Priced per assignment with written proposal.
3. Ozone sterilization contract service: Pilot-scale contract sterilization service scoped and quoted per project. Three-step process: feasibility assessment, ISO 14937 validation, and service delivery. Feasibility assessment leads before any commitment.
4. Revalidation service agreements: Annual revalidation agreements for hospital autoclaves, washer-disinfectors, and low-temperature sterilizers. Fixed per-unit price with annual agreement. Covers equipment requalification and instrument calibration with traceable certificates.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Damgaard Solutions is a Danish GMP engineering consultancy that embeds named senior pharmaceutical engineers within client teams to design, qualify, and validate regulated manufacturing systems. Its offerings cover aseptic isolator filling, clean utilities, environmental monitoring, CIP/SIP, pharma robotics, R&D engineering, washing and sterilization, project management, aseptic isolator rental, ozone sterilization, sterilizer revalidation, and hospital CSSD planning, delivered under fixed-price milestone contracts tied to signed GMP-compliant deliverables.

Product overview

Damgaard Solutions is a Danish GMP engineering consultancy providing specialist pharma engineers embedded within client teams. The offering consists of eight core engineering services (Aseptic Isolator Filling, Clean Utilities, Environmental Monitoring, CIP/SIP, Pharma Robotics, Project Management, R&D Engineering, and Washing & Sterilization) delivered by named senior specialists, supplemented by rental services (Aseptic Isolator Rental), specialty services (Ozone Sterilization), and recurring compliance services (Sterilizer Revalidation, CSSD Planning). All engagements are priced via fixed-price milestones with named CV delivery within 48 hours.

Differentiator

Problem solved

Functional benefit

Products and services

• Aseptic Isolator Filling EU GMP Annex 1 compliant design, qualification, and RABS/isolator integration for pharmaceutical aseptic filling operations. Covers containment strategy, isolator design, and qualification from URS through PQ.
• Clean Utilities Design, qualification, and validation of WFI, purified water, clean steam, and compressed gas systems to GMP specifications. Includes P&ID review and component specifications built for regulatory audit.
• Environmental Monitoring Risk-based EM program design, validation, and 483 remediation. Covers sampling strategy, trending logic, and CAPA frameworks compliant with EU GMP Annex 1, FDA, and ISO 14644.
• CIP / SIP Clean-in-place and steam-in-place system design, validation, and qualification. Includes dead-leg elimination, cycle development, spray coverage verification, and EU GMP Annex 1 compliance.
• Pharma Robotics Robotic handling, filling, and transfer system integration and validation for Annex 1 environments. Covers AGV/AMR integration, SCADA/PLC engineering, and Annex 11/21 CFR Part 11 compliance.
• Project Management Cross-functional project management for CapEx programmes, tech transfers, and facility build-outs. Led by senior GMP engineers with embedded delivery model.
• R&D Engineering Pilot to commercial scale-up engineering with knowledge transfer. Senior process engineers embedded from scale-up conversations through commercial translation, with structured technical documentation packages delivered at close-out.
• Washing and Sterilization Autoclave, washer-disinfector, de-pyrogenation tunnel, and freeze dryer qualification. Covers cycle design, heat distribution/penetration mapping, biological indicator challenges, and relocation requalification.
• Isolator Rental Aseptic isolator rental in Allerod, Denmark with VHP decontamination. Services include VHP studies, BioTrak interference testing, operator training, smoke study pre-testing, and catalyst reactivation. Run by senior engineers.
• Ozone Sterilization Validated low-temperature ozone sterilization for heat- and radiation-sensitive products. Runs at 30-35°C, residue-free (reverts to oxygen and water), validated to ISO 14937. Targets pilot and small-batch scale operations.
• Sterilizer Revalidation Scheduled recalibration and requalification of hospital autoclaves, washer-disinfectors, and low-temperature sterilizers. Covers equipment requalification, instrument calibration, and traceable certificates under ISO 17665, EN 285, and ISO 15883.
• CSSD Planning Central Sterile Services Department full system planning from capacity model to 3D layout. Covers hygienic zoning, device selection, workflow optimization, and traceability design for hospitals.

Quantifiable outcome

• Routine maintenance intervention reduced from half a day to five minutes (MTC redesign at Novo Nordisk HAC Gentofte)
• +3 more outcomes

Named customers9 records

Segments3 records

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Scale indicators7 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• ARCADIS: Global design, engineering, and consulting firm with a life sciences practice serving pharmaceutical manufacturers on facility design, qualification, and sustainability projects. Comparable customer base though much wider portfolio.
• Fluor Corporation: Large global engineering, procurement, fabrication, and construction firm with a life sciences and pharmaceutical manufacturing practice. Overlaps Damgaard on pharma capital projects and qualification, though operates at substantially larger scale.
• GEA Group: Germany-headquartered process engineering and equipment supplier serving pharmaceutical and biopharma manufacturers. Overlaps Damgaard on aseptic processing, separation, and qualification of process systems, though GEA is primarily an OEM rather than a pure specialist consultancy.
• Bilfinger: European industrial services and engineering consultancy with a pharmaceutical and life sciences practice covering qualification, maintenance, and engineering services. Broad incumbent competitor in the European pharma engineering services market.
• Jacobs Solutions: Global engineering, technical, and advisory services firm with a substantial life sciences practice spanning facility design, qualification, and digital solutions. A broad incumbent competitor with deeper bench and balance sheet, serving the same enterprise pharma clients as Damgaard.

Direct peers

• Pharmaplan: Germany-based pharma engineering consultancy (part of TTP Group) specializing in GMP facility design, qualification, and validation for aseptic and biologics manufacturers. Closest continental European peer to Damgaard in terms of mid-sized specialist GMP engineering focus.
• IPS (Integrated Project Services): US-headquartered, global pharma engineering firm focused on process-driven facility design, qualification, and validation. Direct overlap with Damgaard's URS-through-PQ delivery model for aseptic and biologics manufacturers.
• PM Group: Ireland-headquartered international pharma engineering consultancy delivering process architecture, cleanroom design, CQV, and project management. Comparable in offering (full-lifecycle pharma engineering) though operating at materially larger scale than Damgaard.
• NNE A/S: Denmark-headquartered pharma engineering consultancy originally spun out of Novo Nordisk. Direct competitor for Nordic pharmaceutical engineering, qualification, and GMP compliance work — overlapping squarely with Damgaard's aseptic, clean utilities, and validation practice.

Emerging players

• ChargePoint Technology: UK-based specialist in aseptic transfer and containment technology, including isolators, split-butterfly valves, and VHP decontamination. Directly comparable to Damgaard's Allerod aseptic isolator rental capability and aseptic fill-finish qualification practice, though operating more on equipment and less on integrated qualification services.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/damgaardsolutions

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Damgaard Solutions