{"status":"OK","data":{"advertisement":{"id":268704,"title":"ZAPYTANIE OFERTOWE NR VCT/CKD/6/2024  - Us\u0142uga doradztwa dotycz\u0105ca opracowania i testowania lek\u00f3w weterynaryjnych /\nREQUEST FOR QUOTATION No. VCT/CKD/6/2024 - Regulatory advice regarding the development and testing of veterinary medicinal products.","partial_offer_allowed":false,"publication_date":"2024-11-22","submission_deadline":"2024-11-29 23:59:59","planned_sign_date":null,"supplementary_orders":null,"terms_of_contract_change":"zgodnie z zapytaniem ofertowym / according to the request for quotation.","created_at":"2024-11-04 13:38:29","modified_at":"2024-11-30 00:00:06","contact_persons":[{"id":61324,"forename":"Konrad","surname":"Szczukiewicz","phone_number":"+48514448784","email":"konrad@vetcelltech.com","created_by":null,"created_at":"2026-09-07 19:13:31","modified_at":"2026-09-07 19:13:31","modified_by":null}],"orders":[{"id":435157,"estimated_value":null,"order_items":[{"id":490607,"description":"\nWybrany Wykonawca odpowiedzialny b\u0119dzie za wykonanie us\u0142ugi doradztwa regulatorowego dotycz\u0105cego opracowania i testowania lek\u00f3w weterynaryjnych/ \nThe selected Contractor will be responsible for providing regulatory advice on drug development and testing of veterinary medicinal products.\n\nBadany produkt leczniczy to produkt kom\u00f3rkowy oparty o kom\u00f3rki macierzyste do zastosowania w przewlek\u0142ym zapaleniu nerek u kot\u00f3w / \nThe investigational medicinal product is a cellular product based on stem cells for use in chronic kidney disease (CKD) in cats.\n\nDoradztwo regulacyjne i konsultacje obejmuj\u0105 \u0142\u0105cznie maksimum 40 godzin (zdalnie) w zakresie /\nRegulatory advice and consultations include a total of maximum 40 hours (provided remotely) with following scope:\n- opracowania minimalnych wymaga\u0144 bezpiecze\u0144stwa procesu wytwarzania produktu do bada\u0144 pilota\u017cowych / development of minimum safety requirements for the product manufacturing process for pilot studies, \n- opracowania minimalnych wymaga\u0144 kontroli materia\u0142u wyj\u015bciowego i produktu ko\u0144cowego  / development of minimum requirements for the control of the starting material and the final product, \n- sposobu przechowywania i transportu materia\u0142u biologicznego oraz produktu badanego, aby zapewni\u0107 odpowiedni\u0105 jako\u015b\u0107 produktu / storage and transport of biological material and the final product to ensure appropriate product quality, \n- opracowania strategii rejestracyjnej, w tym bada\u0144 pilota\u017cowych i klinicznych / development of a registration strategy, including a pilot and clinical trials \nopracowania wymaganej dokumentacji do przeprowadzenia pilota\u017cowego badania klinicznego m.in.: protok\u00f3\u0142 badania, ustalenia za\u0142o\u017ce\u0144 statystycznych, grupy badanej, kryteri\u00f3w w\u0142\u0105czenia, wykluczenia (medical writing), w tym analiz\u0119 i weryfikacj\u0119 dokumentacji / development of the required documentation to conduct pilot clinical trial, including: study protocol, determination of statistical assumptions, study groups, inclusion/exclusion criteria (medical writing) and analysis and verification of documentation.\n\nDodatkowe informacje / Additional information:\n\n1. Zamawiaj\u0105cy zastrzega sobie prawo do zmiany lub uzupe\u0142nienia tre\u015bci niniejszego zapytania ofertowego. Je\u017celi zmiany b\u0119d\u0105 mog\u0142y mie\u0107 istotny wp\u0142yw na sk\u0142adane   w post\u0119powaniu oferty, Zamawiaj\u0105cy przed\u0142u\u017cy termin sk\u0142adania ofert. Informacja o zmianach zostanie umieszczona tak jak og\u0142oszenie, na stronie Bazy Konkurencyjno\u015bci: https://bazakonkurencyjnosci.funduszeeuropejskie.gov.pl\nThe Ordering Party reserves the right to change the content of this request for quotation. If the changes may have a significant impact on the offers submitted in the procedure, the Ordering Party will extend the deadline for submitting offers. Information about the changes will be placed, just like an announcement, on the Competitiveness Database website (BK2021): https://bazakonkurencyjnosci.funduszeeuropejskie.gov.pl\n\n2. Zamawiaj\u0105cy zastrzega sobie prawo do uniewa\u017cnienia niniejszego zapytania ofertowego bez podania uzasadnienia oraz do pozostawienia post\u0119powania bez wyboru oferty /\nThe Ordering Party reserves the right to invalidate this request for quotation without providing justification and to leave the procedure without selecting an offer.\n\n3. W razie pyta\u0144 do przedmiotu zam\u00f3wienia b\u0105d\u017a sposobu przygotowania oferty, nale\u017cy je sk\u0142ada\u0107 pisemnie na stronie Bazy Konkurencyjno\u015bci poprzez zak\u0142adk\u0119 Pytania:\nhttps://bazakonkurencyjnosci.funduszeeuropejskie.gov.pl\nIf you have any questions about the subject of the order or the method of preparing the offer, they should be submitted in writing on the Competitiveness Database website via the Questions tab: https://bazakonkurencyjnosci.funduszeeuropejskie.gov.pl\n\n","warranty_period":null,"cpv_items":[{"id":8518,"code":"73200000-4","name":"Us\u0142ugi doradcze w zakresie bada\u0144 i rozwoju"}],"timetable_items":[],"fulfillment_places":[{"country":"Polska","voivodeship":null,"poviat":null,"commune":null,"locality":null,"created_by":null,"created_at":"2024-11-22 16:25:01","modified_at":"2024-11-22 16:25:01","modified_by":null,"id":557953,"type":{"id":2,"name":"ca\u0142a Polska"},"group_uuid":"6b0e7260-50d6-472e-a50a-c9586b52fc59"}],"participation_conditions":[{"id":1356356,"description":"Zamawiaj\u0105cy wymaga, aby oferta zawiera\u0142a: \n1. Formularz ofertowy zgodnie z Za\u0142\u0105cznikiem nr 1 do zapytania ofertowego,\n2. O\u015bwiadczenia wynikaj\u0105ce z pkt III zapytania ofertowego i zgodnie z Za\u0142\u0105cznikiem nr 1 do zapytania ofertowego,\n3. Pe\u0142nomocnictwo do wyst\u0119powania w imieniu Wykonawcy (je\u017celi dotyczy).\n\nThe Ordering Party requires that the offer must include:\n1. Proposal Form prepared in accordance with Appendix No. 1 to the request for proposal,\n2. Statements resulting from the provisions of point III of the requests for proposal,\n3. Power of attorney to act on behalf of the Contractor (if applicable).","type":{"id":6,"name":"Lista wymaganych dokument\u00f3w/o\u015bwiadcze\u0144"},"created_by":null,"created_at":"2024-11-04 13:38:29","modified_at":"2024-11-22 16:25:01","modified_by":null,"group_uuid":"85ddc276-bfa2-4590-a12f-d2b53b97020c"},{"id":1356357,"description":"Zamawiaj\u0105cy wymaga od Wykonawcy dysponowania odpowiednim potencja\u0142em kadrowym -  minimum 2 osoby:\n- 1 osoba posiadaj\u0105ca co najmniej roczne do\u015bwiadczenie w rejestracji leku kom\u00f3rkowego  w procedurze centralnej EMA.\n- 1 osoba posiadaj\u0105ce co najmniej roczne do\u015bwiadczenie w rejestracji jednego leku biologicznego w procedurze centralnej EMA.\nWeryfikacja nast\u0105pi w oparciu o o\u015bwiadczenie Wykonawcy o posiadaniu potencja\u0142u kadrowego niezb\u0119dnego do realizacji przedmiotu zam\u00f3wienia, zawarte w Za\u0142\u0105czniku nr 1 \u201cFormularz ofertowy\u201d.\n\nThe Ordering Party requires the Contractor disposal of the appropriate staff potential - at least 2 people:\n-  minimum 1 year experience in marketing authorisation for cellular drug  in centralised procedure in EMA. \n- minimum 1 year experience in marketing authorisation for biological drug in centralised procedure in EMA.\nVerification will be based on the Contractor's statement of having the staff potential necessary to perform the subject of the order, included in Appendix  No. 1 \"Proposal Form\".","type":{"id":2,"name":"Wiedza i do\u015bwiadczenie"},"created_by":null,"created_at":"2024-11-04 13:38:29","modified_at":"2024-11-22 16:25:01","modified_by":null,"group_uuid":"ed58f7c9-92cd-490f-ba6e-6b4f2b94bada"},{"id":1356358,"description":"Zamawiaj\u0105cy wymaga od Wykonawcy posiadania sytuacji ekonomicznej lub finansowej zapewniaj\u0105cej prawid\u0142ow\u0105 realizacj\u0119 zam\u00f3wienia, w szczeg\u00f3lno\u015bci nie znajduje si\u0119 w stanie upad\u0142o\u015bci, restrukturyzacji lub likwidacji.\nWeryfikacja nast\u0105pi w oparciu o o\u015bwiadczenie Wykonawcy, \u017ce znajduje si\u0119 w sytuacji ekonomicznej lub finansowej zapewniaj\u0105cej prawid\u0142ow\u0105 realizacj\u0119 zam\u00f3wienia,                              w szczeg\u00f3lno\u015bci nie znajduje si\u0119 w stanie upad\u0142o\u015bci, restrukturyzacji lub likwidacji, zawarte                  w Za\u0142\u0105czniku nr 1 \u201cFormularz ofertowy\u201d.\n\nThe Ordering Party requires the Contractor having an economic or financial situation that ensures the proper execution of the order, in particular it is not in a state of bankruptcy, restructuring or liquidation.\nVerification will be based on the Contractor's statement that they are in an economic or financial situation that ensures the proper execution of the order, included in Appendix  No. 1 \"Proposal Form\".","type":{"id":5,"name":"Sytuacja ekonomiczna i finansowa"},"created_by":null,"created_at":"2024-11-04 13:38:29","modified_at":"2024-11-22 16:25:01","modified_by":null,"group_uuid":"72ccca56-c5b6-4ba5-9f51-c16f29187883"}],"category":{"id":1,"name":"Us\u0142uga"},"subcategory":{"id":8,"name":"Us\u0142ugi inne"},"created_by":null,"created_at":"2024-11-04 13:38:29","modified_at":"2024-11-22 16:25:01","modified_by":null,"group_uuid":"825d7da0-df4e-4c82-9de9-3a40d07771d0"}],"evaluation_criteria":[{"id":755837,"price_criterion":true,"description":"Cena netto - 100%\nNet price - 100%","created_by":null,"created_at":"2024-11-04 13:38:29","modified_at":"2024-11-22 16:25:01","modified_by":null,"group_uuid":"af8575a8-f6e8-46aa-a379-d5a0ca0d73d6"}],"is_variant":false,"title":"Us\u0142uga doradztwa / regulatory advice ","order_node":{"id":329598},"created_by":null,"created_at":"2024-11-04 13:38:29","modified_at":"2024-11-22 16:25:01","modified_by":null}],"created_by":{"id":61112,"contact_persons":[]},"modified_by":{"modified_by":null,"id":1,"contact_persons":[]},"status":{"id":2,"label":"PUBLISHED","name":"Opublikowane"},"advertiser_address_details":{"name":"VET CELL TECH sp\u00f3\u0142ka z ograniczon\u0105 odpowiedzialno\u015bci\u0105","identification_number_type":"nip","identification_number":"6762639198","address":{"country":"Polska","voivodeship":"ma\u0142opolskie","poviat":"Krak\u00f3w","commune":"Krak\u00f3w-Podg\u00f3rze","locality":"Krak\u00f3w","created_by":null,"created_at":null,"modified_at":null,"modified_by":null,"id":731557,"street":"Profesora Micha\u0142a Bobrzy\u0144skiego","number_description":"14","postcode":"30-348"},"created_by":{"id":61112,"contact_persons":[]},"created_at":"2024-11-04 13:38:29","modified_at":"2024-11-04 13:38:29","modified_by":{"id":61112,"contact_persons":[]},"id":269324},"advertisement":{"id":204059,"number":"2024-61112-204059","publication_date":"2024-11-22","created_by":{"id":61112,"contact_persons":[]},"created_at":"2024-11-04 13:38:29","modified_at":"2024-11-30 00:00:06","modified_by":{"modified_by":null,"id":1,"contact_persons":[]},"status":{"id":6,"label":"RESOLVED","name":"Rozstrzygni\u0119te"},"all_available_version_ids":[268704],"enrollment":null,"projects":[{"id":51253,"name":"\u201eOpracowanie globalnie innowacyjnego leku weterynaryjnego na przewlek\u0142e zapalenie nerek u kot\u00f3w, opartego o allogeniczne kom\u00f3rki macierzyste oraz wdro\u017cenie produkcji w warunkach stand. farmaceut. GMP","number":"0299/23","activity":{"created_by":{"modified_by":null,"id":89,"contact_persons":[]},"created_at":"2023-02-23 09:41:01","modified_at":"2023-02-23 09:41:01","modified_by":{"modified_by":null,"id":89,"contact_persons":[]}},"region":null,"institution":{"created_by":{"modified_by":null,"id":89,"contact_persons":[]},"created_at":"2023-02-23 10:43:43","modified_at":"2023-02-23 10:43:43","modified_by":{"modified_by":null,"id":89,"contact_persons":[]}},"full_number":"FEMP.01.01-IP.01-0299/23","perspective":{},"programme":{"created_by":{"modified_by":null,"id":89,"contact_persons":[]},"created_at":"2023-02-23 09:39:27","modified_at":"2023-02-23 09:39:27","modified_by":{"modified_by":null,"id":89,"contact_persons":[]}},"priority":{"created_by":{"modified_by":null,"id":89,"contact_persons":[]},"created_at":"2023-02-23 09:39:44","modified_at":"2023-02-23 09:39:44","modified_by":{"modified_by":null,"id":89,"contact_persons":[]}},"type":"project","created_by":{"id":61112,"contact_persons":[]},"created_at":"2024-10-15 15:09:35","modified_at":"2024-10-15 15:09:35","modified_by":{"id":61112,"contact_persons":[]}}],"is_author":false,"is_admin":false},"attachments":[{"origin":{"id":268704,"publication_date":"2024-11-22"},"id":1522242,"name":"Zapytanie ofertowe VCT/CKD/6/2024","file":{"id":1696024,"name":"VCT_CKD_06_2024_ZapytanieOfertowe_Doradztwo_22112024.pdf","created_at":"2024-11-22 16:13:38","created_by":{"forename":"Konrad","surname":"Szczukiewicz"},"uri":"/api/files/1696024"},"group_uuid":"7c2d0f0e-836c-4e9c-90db-53f45d67cf1c"},{"origin":{"id":268704,"publication_date":"2024-11-22"},"id":1522243,"name":"Request for quotation VCT/CKD/6/2024","file":{"id":1696027,"name":"VCT_CKD_06_2024_ZapytanieOfertowe_Doradztwo_22112024_ang.pdf","created_at":"2024-11-22 16:14:00","created_by":{"forename":"Konrad","surname":"Szczukiewicz"},"uri":"/api/files/1696027"},"group_uuid":"e5702843-f2a2-4d16-bdad-b914e5447476"},{"origin":{"id":268704,"publication_date":"2024-11-22"},"id":1522244,"name":"Formularz ofertowy VCT/CKD/6/2024","file":{"id":1696043,"name":"VCT_CKD_06_2024_ZapytanieOfertowe_Doradztwo_Zalcznik1_FO_22112024.docx","created_at":"2024-11-22 16:17:00","created_by":{"forename":"Konrad","surname":"Szczukiewicz"},"uri":"/api/files/1696043"},"group_uuid":"88e40b27-0461-42a5-9831-e20af9589c9c"},{"origin":{"id":268704,"publication_date":"2024-11-22"},"id":1522245,"name":"Proposal form VCT/CKD/6/2024","file":{"id":1696047,"name":"VCT_CKD_06_2024_ZapytanieOfertowe_Doradztwo_Zalcznik1_FO_22112024_ang.docx","created_at":"2024-11-22 16:17:33","created_by":{"forename":"Konrad","surname":"Szczukiewicz"},"uri":"/api/files/1696047"},"group_uuid":"45a20acd-a768-4d60-83fd-ec952012f0a1"}]},"dictionaries":{"announcement_status_draft":1,"announcement_status_published":2},"favorite":null,"badge":null,"offer_set_badge_count":null,"question_badge_count":null}}