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End to end CDMO services for the importation, encapsulation and distribution of T3S and Placebo for the LIONNS-D2 Trial
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Descriptions
The School of Medicine successfully applied for a UKRI grant to investigate in a randomised controlled trial (RCT), a new IMP (investigational medicinal product) called Triiodothyronine sulphate (T3S) in hypothyroid subjects with a gene difference in a thyroid related enzyme called deiodinase 2 (D2). We are looking for a CDMO to (i) Import and QP sign off T3S and matched placebo tablets obtained from Ardena, Pamplona, Spain who will manufacture these to GMP standards; (ii) over encapsulate commercially secured L-thyroxine (LT4 ) and matched placebo capsules; (iii) store T3S and matched placebo obtained from Ardena, and over encapsulated LT4 and matched placebo; (iv) label T3S, LT4 and respective placebo packs for distribution to trial subjects; (v) distribute T3S and matched placebo and over encapsulated LT4 and matched placebo packs to trial pharmacy (Royal Glamorgan Hospital, Wales).
Timeline
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CPV Codes
73100000 - Research and experimental development services
33600000 - Pharmaceutical products
Keywords
medicinal drugs
product analysis
field trials
prescription medicines
prototype development
test implementation
experimental studies
pharmaceutical compounds
scientific research
laboratory testing
technology investigation
discovery research
innovation modeling
generic pharmaceuticals
active pharmaceutical ingredients
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1 Tender Lots
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