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We solve uncertainties related to your  construction and  renovation projects  

We provide the necessary experts to achieve GMP compliance with peace of mind ​

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Qualification & Validation

"We ensure our clients to achieve GMP compliance after installing new equipment to their sitesMonika Brazda, Co-Owner & Team Lead QBDC CH

We achieve this by providing the necessary experts

  • Set Strategy with  strict schedule with milestones
  • Huge Templates Basket for Jump Start
  • Regular Meetings for Status Updates  

This means for our clients  achieve GMP compliance with peace of mind


  • Solid plan in place that sets clear goals following SMART methodology to keep track
  • Keep everyone in the loop by holding regular meetings to provide status updates 


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Document Creation

Our comprehensive document creation services ensure that your qualification activities are meticulously planned, executed, and documented to meet the highest standards of compliance and quality.  The Qualification Team ensures all qualification documents, like protocols and reports, are accurate, complete, and meet Good Manufacturing Practices (GMP).

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Project 

Management

We use a risk-based qualification strategy that targets critical systems, saving time and costs by skipping unnecessary qualifications. This not only enhances compliance with regulations for high-risk systems but also helps maintain product quality and patient safety. 

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GMP-upgrades of leverage facilities

As a biotech qualification specialist, our GMP-upgrades service ensures that your facilities remain compliant with evolving GMP regulations and adapt to changes in your product portfolio. Here’s how we achieve this!

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CMC Development

 We ensure compliance with regulatory standards, optimize product development, and enhance manufacturing processes, ultimately leading to high-quality, safe and effective biopharmaceutical products.  

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Bioprocessing & PAT

We help our clients streamline bioprocesses to reduce costs and improve quality, all tailored to their needs. Our tool, EDDI, provides complete cell data for precise characterization, eliminating guesswork and enabling informed decisions.

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Let´s talk how we can assist you!