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Testing with Compliance and Confidence
Products and consultancy to meet clinical and ISO 15189 regulatory needs for rare disorders and in-house procedures.
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Products and consultancy to meet clinical and ISO 15189 regulatory needs for rare disorders and in-house procedures.
Our team, with experience with aligning clinical requirements to regulations will provide the validations required to stay complainant in these scenarios.
Implementation of clinical testing platforms is challenging and usually only reserved for specialist laboratories.
Our team provides full validation services, training and or assay protocol and samples to assist development of diagnostic assays.
Consumer surveys reveal that '70% of assays or devices required for critical diagnostic use took over 1 year from procurement to make services live'.
We think this too long and impacts patient safety. With our specialists, the lead time from implementation is completed end to end within 1month.
Set up testing for ADAMTS13 activity, antigen, open/close, IgG antibody and functional antibody assays for both clinical and research use.
Assays will be set up for direct user applications, accurately monitor patients on any Standard Of Care (SOC) or research therapeutics.
INNOVATIVE PRODUCTS & SOLUTIONS FOR RARE DISORDERS.
Provide assurances with our confirmatory ISO-Check product range to support diagnosis and monitoring of TTP.
We provides consultancy and tailored solutions to ensure your laboratory meets the necessary standards and regulations to help fulfil the requirements of ISO 15198,2022.
Enlist a specialist to take the hassle of the ISO 15189 accreditation process of any equipment or processes you require!
Haemostasis Training for FRCPath exams, Quality assurances, Assay development, Assay limitations, Diagnosis pathways and and much more tailored for the individual or the organization.
The inability to prevent ischemic stroke or major vascular events despite optimal use of anti-platelet medications is multi-factorial hence we evaluate using a multiple marker model for a tailor made assessment for the individual.
Require ADAMTS13 recombinant made or Antibodies eluted?
Require samples for research or validations?
We routinul cover services throughout UK and Europe, Australia, NZ. Slowly we growing in other countries so we would love to hear from you no matter where you are located.
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