GMP ENGINEERING · EUROPE & GULF

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.

COMPANIES WE HAVE WORKED WITH
—WHAT WE DO

Five disciplines, one embedded team.

We don't send advisors. We send 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

EU GMP Annex 1 design, qualification, and RABS/isolator integration.

Industrial stainless steel machinery with control panel and multiple vertical pipes in a clean facility.
Utilities

WFI, purified water, and clean steam systems. designed and qualified.

Person in full protective suit squatting in a cleanroom hallway interacting with a device on a stool.

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

Industrial robotic arm with a suction cup end effector operating in a factory setting.
Automation

Robotics & Automation

SCADA, PLC, and CSV/CSA. integrated from engineering through validation.

Person in white protective suit, face mask, and gloves handling a stainless steel rack in a sterilization machine.
Infrastructure

Water & Steam Systems

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

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 case
—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.

Ready to get started?
So are we.

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