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Photostability Testing as per the ICH Q1B guidelines should play a vital part of new pharmaceutical substance and drug products.
Thermal Cycling will allow the appropriate tests to be carried out to avoid adverse effects when a product is transported.
If you would like to outsource the storage of controlled drugs to us, our Rochdale facility is licenced with a UK Home Office Controlled Drugs licence for the storage of controlled drugs.
The introduction of new or modified medical devices requires evidence that they can be stored or used without any deleterious effects on performance that may impact patient safety and efficacy.
Quality is at the core of our business here at Astoriom. Our dedicated teams work to ISO 9001:2015 Standards and EU/US GMP Regulations while adhering to Data Integrity Guidelines to meet and satisfy our customer quality requirements across the globe.
Astoriom's highly trained Field Service Engineers conform to cGMP guidelines and can undertake every aspect of calibration and validation.
Astoriom - FDA-registered and compliant to cGMP, MHRA, HPRA and DEA guidelines- has over 30 years of experience offering a full range of Stability Storage Solutions to the UK, Ireland and US pharmaceutical and medical device sectors. Our facilities with 21 CFR part 11 compliant equipment offer long and short shelf life studies under specified ICH or non-ICH conditions. Our extensive Quality Management System provides overall management, accuracy and control over the Stability and Storage of your samples.
Billions of biosamples are collected each year for a plethora of studies, including research and clinical applications. One of the most pressing concerns for these samples is storage.