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Engineered in Europe — Built for the Gulf

Future proof pharma factories — engineered in Europe, delivered with Middle East expertise.

Damgaard Solutions is a consultancy company with senior engineers who have delivered compliant, automated facilities for leading European manufacturers.

Standards we work to: 

  • EU GMP Annex 1 ·
  • ISPE GAMP 5
  • 21 CFR Parts 11/210/211
  • USP/EP/JP Pharmacopoeias
  • ISO 14644 Cleanrooms

Designed for the Middle East

Our team partners with owners and Engineering, procurement and Construction management firms across Scandinavia and in Saudi Arabia to deliver compliant, automated, and inspection ready facilities.

  • Alignment with SFDA (Saudi Food Drug & Drug Authority ), MOH (Ministry of Health), and GCC (Gulf Cooperation Council) guidelines; we map FDA/EMA expectations to local requirements.
  • Owner’s engineer or procurement support; vendor neutral selection and technology transfers.
  • English documentation and structured on-site training programs.
  • FAT/SAT, DQ/IQ/OQ/PQ qualification, Cycle validation.
  • Robotics and digitalization (MES, SCADA and PLC).

We support confidential conceptual studies, brownfield upgrades, and greenfield projects.

What we do

  • Aseptic Processing & Containment — Isolators, RABS, VHP bio-decontamination strategies, aseptic fill-finish lines, and cleaning validation.
  • Sterilization & Washing — Autoclaves, de-pyrogenation tunnels, GMP washers (utensils/components), freeze dryers, cycle design and qualification.
  • Utilities & Cleanrooms — HVAC, WFI/Clean Steam/CIP/SIP, ISO 14644 Environmental monitoring, sampling, study and validation.
  • Robotics & Automation — Collaborative robotics, AGVs/AMRs, line integration, safety, and IT/OT/PLC/SCADA.
  • CSV / CSA & Data Integrity — Risk based validation (GAMP 5), 21 CFR Part 11, audit trails.

How we work​

  • 1. Discovery & GAP MAP— Rapid workshops to define scope, constraints, and a compliance map aligned to EU GMP/SFDA/FDA.
  • 2. Concept & Design — Layouts, URS/FS/DQ packages, vendor RFQ and evaluation with clear compliance requirements.
  • 3. Execution — Owner’s engineer or procurement support; factory/site tests (FAT/SAT), commissioning, and risk management.
  • 4. Qualification & CSV — Risk based qualification (IQ/OQ/PQ), data integrity, and inspection readiness.
  • 5. Handover & Training — SOPs, bilingual documentation, on-site training, and performance monitoring.

Who we serve

  • Biologics, sterile injectables, vaccines, hospital pharmacies, advanced therapy facilities (ATMP), and CDMOs.

Start a confidential conversation.

Tell us about your project and we’ll respond within one business day.

We’re based in Copenhagen, Denmark serving KSA, UAE, Qatar, Kuwait, Bahrain & Oman.

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Compliance & Legal We support clients in achieving compliance with FDA/EMA/SFDA expectations and leading pharmacopoeias. Damgaard Group does not claim agency over regulatory approvals.