End to end CDMO services for the importation, encapsulation and distribution of T3S and Placebo for the LIONNS-D2 Trial

Tender description

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).