Tenders Are Invited For Research And Experimental Development Services – Zp/Czd/063/26 Service For The Development And Production Of Placebos, Preparation Of Full Placebo Documentation And Repackaging, Labeling And Release Of The Medicinal Product Revatio 10 Mg/Ml Or Equivalent And Placebo For Use In The Non-Commercial Mitbrain Clinical Trial (...)

Research And Experimental Development Services – Zp/Czd/063/26 Service For The Development And Production Of Placebos, Preparation Of Full Placebo Documentation And Repackaging, Labeling And Release Of The Medicinal Product Revatio 10 Mg/Ml Or Equivalent And Placebo For Use In The Non-Commercial Mitbrain Clinical Trial (...). Description Of The Subject Of The Order The Subject Of The Order Is The Service Of Developing And Manufacturing A Placebo, Preparing Full Placebo Documentation And Repackaging, Labeling And Releasing The Medicinal Product Revatio 10 Mg/Ml Or Equivalent And Placebo For Use In The Non-Commercial Clinical Trial Mitbrain Exploratory Clinical Trial With Randomized Initiation Of Treatment, Aimed At Assessing The Safety And Effectiveness Of Sildenafil Treatment In Pediatric Patients With Mitochondrial Disease Presenting With Neurological Symptoms In Accordance With The Principles Set Out In Proposed Provisions Of The Contract (Appendix No. 2 To The Swz) In Quantities Resulting From Current Needs And Within The Deadlines Specified In The Concluded Contract. The Service Includes: 1. Preparation Of A Placebo Formulation - Powder For Oral Suspension Fully Corresponding In Appearance, Consistency, Taste, Smell And Stability (Both Before And After Dissolution) To The Tested Preparation, I.E. Revatio 10Mg/Ml Or Equivalent - Marketing Authorization Number: Eu/1/05/318/003. The Produced Placebo Must Reproduce The Physicochemical, Taste, Smell And Visual Characteristics Of The Tested Medicinal Product, Without The Content Of The Active Substance, Ensuring Appropriate Quality Parameters And Compliance With The Principles Of Good Manufacturing Practice (Gmp). 2. Preparation Of Full Impd Documentation For The Manufactured Placebo For The Purposes Of Registration Of The Study In Ctis By August 28, 2026. 3. Accelerated Stability Studies Plus Full Microbiological Studies For Placebo. 4. Purchase Of The Necessary Raw Materials And Packaging Materials To Produce The Placebo. 5. Production Of A Series Of Placebos In The Number Of 200 Packages, Originally Packed In Bottles With A Shape And Color Identical (Or Impossible To Distinguish By The Patient And The Researcher) As The Test Preparation. 6. Adding To The Placebo Bottles The Remaining Packaging Elements Identical (Or Impossible To Distinguish By The Patient And The Researcher) As In The Test Preparation: A Polypropylene Measuring Cup (Scaled To Measure 30 Ml), A Polypropylene Oral Syringe (3 Ml), An Hdpe Plunger, An Ldpe Bottle Connector. 7. Packing Placebo Bottles And Other Packaging Elements In Outer Packaging. 8. Purchase And Import Of An Investigational Product, I.E. Revatio 10Mg/Ml Or Equivalent From Another Eu Country, In The Amount Of 1,260 Packages. 9. Removing The Original Labels From The Immediate Packaging Of The Test Preparation. 10. Repackaging The Original Study Preparation Into Outer Packaging Identical To The Placebo. 11. Labeling Of Immediate Packaging And Outer Packaging Of The Test Preparation And Placebo According To Label Templates Registered By The Office For Registration Of Medicinal Products And Based On Prepared Randomization Lists. 12. Ensuring Complete Blinding Of The Packaging Of The Original Investigational Preparation And Placebo From The Patient And The Investigator. 13. Ensuring That Issued Packaging Of The Original Test Preparation And Placebo Can Be Unblinded Only In Accordance With Art