Become part of the team

We aim for the right level the first-time round


Let us assume responsibility for your compliance with the expectations of the public authorities and for making sure that you are always ready for inspection

When we create validation master plans, validation plans, risk assessments and requirement specifications, we take the entire validation process into account and do our best to ensure sound project execution. We always resolve problems as early as possible in the course of the project, so that solutions are as easy and inexpensive as possible. It also prevents delays further down the line.

We are happy to undergo an extra review round to get the perfect result, but we also make sure to match the level to our clients’ needs.

We quickly get a grasp of each client’s quality system, and we have a solid understanding of the expectations and inspections of the public authorities, thanks to our many years’ experience in the industry. We thus ensure that the individual document and validation can always be backed by an internal audit or an external inspection.

We are particularly strong within validation of IT and Automation systems in connection with production equipment, but we also validate non-automated production equipment. Overall, our specialists cover everything from HVAC systems to fermentation processes and purification steps in tablet production, aseptic filling, freeze drying and packing, including sterilisation. We ensure a high level of data integrity throughout.

If the client lacks qualified QA resources, these can also be provided. However, we are reluctant to provide QA resources – on behalf of the client – for approval of documents that our specialists have prepared. This is because there should never be doubts concerning how well we did our job.

"Validation is about prevention of faults. My most important task is to ensure that things work as intended, and I plan my projects with the approach that validation and qualification must be incorporated from day one."
Tine Lykke Bank
Senior Consultant

Validation contact

Mads Mejer Nielsen

Senior Consultant and Department Head
  • Project Management
  • IT & Automation / GAMP
  • GMP / Validation
  • Aseptic Processes

Michael Elsborg Andreasen

Senior Consultant
  • Project Management
  • IT & Automation / GAMP
  • GMP / Validation
  • Equipment & Processes

Poul Petersen

Senior Consultant
+45 22 38 85 30
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