Poland – Research and experimental development services – ZP/CZD/063/26 Usługa opracowania i wytworzenia placebo, przygotowania pełnej dokumentacji placebo oraz przepakowania, etykietowania i zwolnienia produktu leczniczego Revatio 10 mg/ml lub równoważnego oraz placebo do stosowania w niekomercyjnym badaniu klinicznym MITBRAIN (...)

The tender seeks a contractor for the development, production, labeling, and release of placebo and the repackaging of the medicinal product Revatio 10 mg/ml (or equivalent) for a non-commercial clinical trial (MITBRAIN) in pediatric patients with mitochondrial disease. The services include placebo formulation, IMPD documentation, accelerated stability testing, procurement of raw materials, production of 200 placebo units, import of 1,260 units of Revatio from an EU country, removal of original labels, repackaging, labeling, blinding, randomisation code insertion, QP release, storage, and distribution. The contract duration is 48 months with quantities based on current needs. Award is 100% price. The sole eligibility requirement is possession of a valid Polish pharmaceutical wholesale permit (GIF). Submission deadline: 2026-06-23 at 08:55 CEST.