Tenders Are Invited For Research And Experimental Development Services - Manufacturing, Labeling, Release By ... in Poland

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Research And Experimental Development Services - Manufacturing, Labeling, Release By A Qualified Person (Confirming Compliance With Gmp And Quality Assurance Requirements; Qa/Qp Release), Storage, Transport Including Delivery On The Day Of The Patients Visit, Disposal And Comprehensive Documentation (Impd/Ib) Of The Investigational Medicinal Product Containing The Active Substance Psilocybin And Comparators (Ssri) (...). 1. The Subject Of This Order Is The Service Of Manufacturing, Labeling, Release By A Qualified Person (Confirming Compliance With Gmp And Quality Assurance Requirements; Qa/Qp Release), Storage, Transport Including Delivery On The Day Of The Patients Visit, Disposal And Comprehensive Preparation Of Documentation (Impd/Ib) Of The Investigational Medicinal Product Containing The Active Substance Psilocybin And Comparators (Ssri) For The Purposes Of Implementing The Project In One Research Center Non-Commercial Clinical Trial Entitled: Randomized, Open, Controlled Study Aimed At Assessing The Effectiveness And Safety Of Psilocybin In The Treatment Of Treatment-Resistant Depression, Administered Together With Ssris Or After Gradual Discontinuation Of Ssris, Compared With Standard Ssri Treatment Financed From The State Budget By The Medical Research Agency Under Contract No. 2024/Abm/01/00043-00 Of December 10, 2024. 2. The Contractors Obligations Will Include The Implementation Of The Subject Of The Order In Accordance With The Description Of The Subject Of The Order, Constituting Annex No. 2 To The Swz, Under The Conditions Specified In The Draft Agreement, Constituting Annex No. 6 To The Swz.

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