References · Anonymised · Case studies
Initial situation, procedure, result.
Real projects, anonymous at the client's request. Every case shows what someone came to us with, what we did and what the outcome was. No glossy brochures, but what you need to assess whether we fit your project.
Medicinal Product Release
View this serviceSponsor of clinical trials, small biotech company
Active substance from a third country, release for the clinical trial
A sponsor without its own QP needed GMP oversight for manufacture in a non-EU country, the IMPD and release of the investigational medicinal prod...
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Large international pharmaceutical company
Method transfer and EU retesting for launch from a third country
Analytical method transfer to our laboratory, EU retesting, import and warehousing with a logistics partner. Launch planned for 2027.
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Mid-sized company. Marketing authorisation holder and pharmaceutical entrepreneur
Qualified Person (QP) and Head of Production provided
Following a personnel shortage, our appointed persons secured batch release and the QM system, and business operations continued without interrup...
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Medium-sized company. Contract manufacturer of medicinal products
Batch release after EU import for a Swiss contract manufacturer
Continuous release of commercial medicinal products following import into the EU, plus advice on changes and operational QM support.
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Strategic GxP Consulting & QA Support
View this serviceSponsor of clinical trials, small biotech company
From the IMPD to release, all from a single source
Active substance manufacture in a non-EU country, formulation development, analytics and QP release: a project combining almost all of our servic...
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Innovative biotech company in the field of cancer therapeutics
Establishing a GMP manufacturing facility for peptide vaccines
A renowned research institution is setting up a manufacturing facility for personalised peptide vaccines, we support them from regulatory affairs...
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Regulatory Affairs
View this serviceConfidentiality
Why there are no names here.
Anyone who brings in a Qualified Person from outside or has a batch tested analytically rarely makes a big fuss about it. That's why our cases are anonymised: You read the initial situation, the procedure and the result, but not the company name.
In the initial consultation we can be more specific, as far as our confidentiality agreements allow. And if you would like to speak to a reference, we will ask for you.
