References · Anonymised · Case studies
Starting point, approach, outcome.
Real projects, anonymised at our clients' request. Each case shows what the client came to us with, what we did and what the outcome was. No glossy brochure, just what you need to judge whether we are the right fit for your project.
QP Batch Release
View this serviceClinical trial sponsor, biotech company
Comparator sourced, labelled and released
An authorised medicinal product was to serve as a comparator in a clinical trial. We oversaw its GMP-compliant sourcing and labelling and release...
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International pharmaceutical services company headquartered in the USA with locations in the EU
Compassionate use programme: QP release
Patients were to receive a medicinal product not yet authorised for their indication. We oversaw its GMP-compliant transfer into the compassionat...
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Clinical trial sponsor, small innovative biotech company
Novel manufacturing process, supported through to phase 2a
A multi-stage manufacturing process with many manual steps was to be automated in compliance with GMP. The phase 2a trial went ahead, and product...
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Clinical trial sponsor, small biotech company
Third-country active substance: QP release for a clinical trial
Active substance from a non-EU country, investigational medicinal product for a trial in several European countries: we provided GMP oversight, t...
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Large international pharmaceutical company
Method transfer and EU retesting for a third-country product launch
A marketing authorisation holder is planning to launch a medicinal product made in a non-EU country. We handle method transfer, EU retesting, imp...
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Mid-sized pharmaceutical company and marketing authorisation holder
Qualified Person (QP) and Head of Production provided
A marketing authorisation holder needed a Qualified Person (QP) for batch release and, for a period, a Head of Production. We provided both, and...
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Mid-sized contract manufacturer of medicinal products
QP batch release after EU import for a Swiss contract manufacturer
A Swiss contract manufacturer needs batch release for its authorised medicinal products after import into the EU. We release every batch on an on...
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GMP and GxP Consulting & QA Support
View this serviceClinical trial sponsor, small biotech company
From IMPD to QP release, all from a single provider
A new active substance from a non-EU country was to be used in a phase 1 trial as an investigational medicinal product. We provided GMP oversight...
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Innovative biotech company in cancer therapeutics
Setting up a GMP manufacturing facility for peptide vaccines
A research institution is setting up a GMP manufacturing facility for personalised peptide vaccines. We are supporting it from regulatory classif...
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Regulatory Affairs
View this serviceConfidentiality
Why there are no names here.
Companies that bring in an external Qualified Person or have a batch retested rarely advertise the fact. That is why our cases are anonymised: you read the starting point, the approach and the outcome, but not the company name.
In an initial consultation we can go into more detail, as far as our confidentiality agreements allow. If you would like to speak to a reference, we will ask one of our clients on your behalf.
