{"status":"OK","data":{"advertisement":{"id":337660,"title":"ZAPYTANIE OFERTOWE nr VCT/CKD/14/2025 Us\u0142uga doradztwa regulatorowego dotycz\u0105cego opracowania i testowania lek\u00f3w weterynaryjnych (CKD \u2013 Chronic Kidney Disease).\n\nREQUEST FOR QUOTATION No VCT/CKD/14/2025 Regulatory advice on drug development and testing of veterinary medicinal products (CKD \u2013 Chronic Kidney Disease).","partial_offer_allowed":false,"publication_date":"2025-12-23","submission_deadline":"2026-01-08 23:59:59","planned_sign_date":null,"supplementary_orders":"Zamawiaj\u0105cy zastrzega sobie prawo do udzielenia Wykonawcy zam\u00f3wienia uzupe\u0142niaj\u0105cego (zgodnego z opisem przedmiotu zam\u00f3wienia podstawowego) w wysoko\u015bci nieprzekraczaj\u0105cej 50% warto\u015bci zam\u00f3wienia podstawowego okre\u015blonej w umowie zawartej z Wykonawc\u0105.\nThe Ordering Party reserves the right to award the Contractor a supplementary contract (consistent with the description of the basic contract) in an amount not exceeding 50% of the value of the basic contract specified in the agreement concluded with the Contractor.","terms_of_contract_change":"Zgodnie z zapytaniem ofertowym /according to the request for quotation.","created_at":"2025-12-04 11:12:05","modified_at":"2026-01-09 00:00:15","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":545197,"estimated_value":null,"order_items":[{"id":614474,"description":"Wybrany Wykonawca odpowiedzialny b\u0119dzie za wykonanie us\u0142ugi doradztwa regulatorowego dotycz\u0105cego opracowania i testowania lek\u00f3w weterynaryjnych (CKD \u2013 Chronic Kidney Disease).\nThe selected Contractor will be responsible for providing regulatory advice on drug development and testing of veterinary medicinal products (CKD \u2013 Chronic Kidney Disease).\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.\nDoradztwo regulacyjne i konsultacje (\u015bwiadczone zdalnie) w zakresie:\nopracowanie dokumentacji wymaganej do uzyskania pozwolenia na dopuszczenie do obrotu i zgodno\u015bci z wymogami dla biologicznych lek\u00f3w weterynaryjnych stawianych przez regulator\u00f3w (medical writing), w tym analiz\u0119 i weryfikacj\u0119 dokumentacji,\nprojektowanie badania klinicznego, w tym ustalenia za\u0142o\u017ce\u0144 statystycznych, grupy badanej, kryteri\u00f3w w\u0142\u0105czenia, wykluczenia i schematu wizyt w oparciu o informacje dostarczone przez Zamawiaj\u0105cego, dane literaturowe dotycz\u0105ce CKD, przeprowadzonych bada\u0144 przedklinicznych i klinicznych,\nopracowanie wymaganej dokumentacji do uzyskania zgody i przeprowadzenia pilota\u017cowego badania klinicznego, w tym protoko\u0142u pilota\u017cowego badania klinicznego, formularza \u015bwiadomej zgody (ICF), karty obserwacji klinicznej (CRF) (medical writing), w tym analiz\u0119 i weryfikacj\u0119 dokumentacji.\n\nRegulatory advice and consultations (provided remotely) with following scope:\nPreparation of the documentation required to obtain marketing authorization and compliance with the regulatory requirements for biological veterinary medicinal products (medical writing), including analysis and verification of documentation;\nDesign of the clinical study, including the establishment of statistical assumptions, study population, inclusion and exclusion criteria, and visit schedule based on the information provided by the Client, literature data on CKD, and the results of conducted preclinical and clinical studies;\nPreparation of the documentation required to obtain approval for and conduct a pilot clinical study, including the pilot clinical study protocol, informed consent form (ICF), and clinical observation form (CRF) (medical writing), including analysis and verification of documentation.\n\n\nJe\u015bli w opisie przedmiotu zam\u00f3wienia wyst\u0119puj\u0105: nazwy konkretnego produktu, normy jako\u015bciowe, nazwy w\u0142asne, patenty, znaki towarowe, typy, standardy nale\u017cy to traktowa\u0107 jedynie jako pomoc w opisie przedmiotu zam\u00f3wienia. W ka\u017cdym przypadku dopuszczalne s\u0105 rozwi\u0105zania r\u00f3wnowa\u017cne pod wzgl\u0119dem funkcjonalno\u015bci, jako\u015bci. Je\u017celi w opisie przedmiotu zam\u00f3wienia wskazano jakikolwiek znak towarowy, patent czy pochodzenie - nale\u017cy przyj\u0105\u0107, \u017ce wskazane patenty, znaki towarowe, pochodzenie okre\u015blaj\u0105 parametry techniczne, eksploatacyjne, u\u017cytkowe, co oznacza, \u017ce Zamawiaj\u0105cy dopuszcza z\u0142o\u017cenie ofert w tej cz\u0119\u015bci przedmiotu zam\u00f3wienia o r\u00f3wnowa\u017cnych parametrach. Obowi\u0105zek wykazania r\u00f3wnowa\u017cno\u015bci spoczywa na Wykonawcy. W razie w\u0105tpliwo\u015bci, co do r\u00f3wnowa\u017cno\u015bci poszczeg\u00f3lnych element\u00f3w Zamawiaj\u0105cy wezwie Wykonawc\u0119 do z\u0142o\u017cenia dodatkowych wyja\u015bnie\u0144 lub dokument\u00f3w.\nIf the description of the subject of the contract includes specific product names, quality standards, proprietary names, patents, trademarks, types, or standards, these shall be treated solely as an aid in describing the subject of the contract. In all such cases, solutions equivalent in terms of functionality and quality are acceptable. If the description of the subject of the contract indicates any trademark, patent, or origin, it shall be understood that the indicated patents, trademarks, or origin define technical, operational, and functional parameters, meaning that the Ordering Party allows the submission of offers including equivalent parameters within this part of the subject of the contract. The Contractor is responsible for demonstrating equivalence. In case of doubts regarding the equivalence of specific elements, the Ordering Party may request the Contractor to submit additional explanations or documents.\n\nDodatkowe informacje / Additional information:\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\ntak 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: https://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 ompetitiveness 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":"ma\u0142opolskie","poviat":"Krak\u00f3w","commune":"Krak\u00f3w-Podg\u00f3rze","locality":"Krak\u00f3w","created_by":null,"created_at":"2025-12-04 12:21:46","modified_at":"2025-12-23 12:04:08","modified_by":null,"id":696466,"type":{"id":1,"name":"adres"},"group_uuid":"51a2cd76-4a32-4ac4-992d-c9b8aecdffde"}],"participation_conditions":[{"id":1737044,"description":"Wykonawca posiada wiedz\u0119 i do\u015bwiadczenie umo\u017cliwiaj\u0105c\u0105 poprawn\u0105 realizacj\u0119 zam\u00f3wienia tj. przeprowadzi\u0142 proces rejestracji przynajmniej 1 leku kom\u00f3rkowego oraz 1 leku biologicznego w procedurze centralnej EMA.\nThe Contractor has the knowledge and experience necessary to properly perform the contract, i.e., has carried out the registration process of at least one cellular drug and one biological drug in a centralised procedure in EMA\n\nWeryfikacja nast\u0105pi w oparciu o o\u015bwiadczenie Wykonawcy, zawarte w Za\u0142\u0105czniku nr 1 \u201cFormularz ofertowy\u201d.\nVerification will be based on the Contractor's statement, included in Appendix  No. 1 \"ProposalForm\".\n\nZamawiaj\u0105cy mo\u017ce \u017c\u0105da\u0107 od Wykonawc\u00f3w dokument\u00f3w potwierdzaj\u0105cych tre\u015b\u0107 z\u0142o\u017conych o\u015bwiadcze\u0144.  Dowody potwierdzaj\u0105ce tre\u015b\u0107 o\u015bwiadcze\u0144 to m.in. referencje, protoko\u0142y odbioru, CV  lub innymi wiarygodnymi dokumentami po\u015bwiadczaj\u0105cymi wskazane do\u015bwiadczenie i kwalifikacje\nThe Ordering Party might request additional verification of the information provided in the declaration and documents confirming the content of the statements. Evidence confirming the content of the statements includes, among others, references, acceptance protocols, CVs, or other reliable documents attesting to the indicated experience and qualifications.","type":{"id":2,"name":"Wiedza i do\u015bwiadczenie"},"created_by":null,"created_at":"2025-12-04 12:21:46","modified_at":"2025-12-23 12:04:08","modified_by":null,"group_uuid":"ee36cad8-f2bb-4daa-8550-04d6d5f6490a"},{"id":1737045,"description":"Zamawiaj\u0105cy wymaga, aby zesp\u00f3\u0142 projektowy, kt\u00f3ry b\u0119dzie zaanga\u017cowany z ramienia Wykonawcy do realizacji zam\u00f3wienia dysponowa\u0142 odpowiednim potencja\u0142em kadrowym zdolnym do wykonania zam\u00f3wienia:\n 1 osoba posiadaj\u0105ca co najmniej 1 rok do\u015bwiadczenia w rejestracji leku kom\u00f3rkowego lub biologicznego  w procedurze centralnej EMA.\nThe Contractor must assign a project team possessing the following minimum professional qualifications and capabilities for the effective execution of the contract:\n- minimum 1year experience in marketing authorisation for cellular drug or biological drug in centralised procedure in EMA.\n\nZamawiaj\u0105cy wymaga, aby osoby wyznaczone do realizacji zam\u00f3wienia zna\u0142y aktualne przepisy krajowe i wsp\u00f3lnotowe w zakresie formalnych i regulacyjnych aspekt\u00f3w rejestracji weterynaryjnych produkt\u00f3w leczniczych i prowadzenia weterynaryjnych bada\u0144 klinicznych.\nThe Ordering Party  requires that the persons assigned to perform the contract are familiar with the current national and EU regulations regarding the formal and regulatory aspects of the registration of veterinary medicinal products and the conduct of veterinary clinical trials.\n\n\nWeryfikacja nast\u0105pi w oparciu o o\u015bwiadczenie Wykonawcy, zawarte w Za\u0142\u0105czniku nr 1 \u201cFormularz ofertowy\u201d.\nVerification will be based on the Contractor's statement, included in Appendix  No. 1 \"ProposalForm\".\n\nZamawiaj\u0105cy mo\u017ce \u017c\u0105da\u0107 od Wykonawc\u00f3w dokument\u00f3w potwierdzaj\u0105cych tre\u015b\u0107 z\u0142o\u017conych o\u015bwiadcze\u0144.  Dowody potwierdzaj\u0105ce tre\u015b\u0107 o\u015bwiadcze\u0144 to m.in. referencje, protoko\u0142y odbioru, CV  lub innymi wiarygodnymi dokumentami po\u015bwiadczaj\u0105cymi wskazane do\u015bwiadczenie i kwalifikacje.\nThe Ordering Party might request additional verification of the information provided in the declaration and documents confirming the content of the statements. Evidence confirming the content of the statements includes, among others, references, acceptance protocols, CVs, or other reliable documents attesting to the indicated experience and qualifications.","type":{"id":4,"name":"Osoby zdolne do wykonania zam\u00f3wienia"},"created_by":null,"created_at":"2025-12-04 12:21:46","modified_at":"2025-12-23 12:04:08","modified_by":null,"group_uuid":"53807314-9d4b-477b-9a62-bd45798f06ed"},{"id":1737046,"description":"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.\nHaving 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\n\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\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":"2025-12-04 12:21:46","modified_at":"2025-12-23 12:04:08","modified_by":null,"group_uuid":"c173cbe7-eb80-4487-84af-779944954ebc"},{"id":1737047,"description":"1. Zakaz konfliktu interes\u00f3w \nZam\u00f3wienie nie mo\u017ce zosta\u0107 udzielone podmiotom powi\u0105zanym osobowo lub kapita\u0142owo z Zamawiaj\u0105cym.\nPrzez powi\u0105zania kapita\u0142owe lub osobowe rozumie si\u0119 wzajemne powi\u0105zania mi\u0119dzy beneficjentem lub osobami upowa\u017cnionymi do zaci\u0105gania zobowi\u0105za\u0144 w imieniu beneficjenta lub osobami wykonuj\u0105cymi w imieniu beneficjenta czynno\u015bci zwi\u0105zane z przeprowadzeniem procedury wyboru wykonawcy a wykonawc\u0105, polegaj\u0105ce w szczeg\u00f3lno\u015bci na:  \na) uczestniczeniu w sp\u00f3\u0142ce jako wsp\u00f3lnik sp\u00f3\u0142ki cywilnej lub sp\u00f3\u0142ki osobowej, posiadaniu co najmniej 10% udzia\u0142\u00f3w lub akcji (o ile ni\u017cszy pr\u00f3g nie wynika z przepis\u00f3w prawa), pe\u0142nieniu funkcji cz\u0142onka organu nadzorczego lub zarz\u0105dzaj\u0105cego, prokurenta, pe\u0142nomocnika,\nb) pozostawaniu w zwi\u0105zku ma\u0142\u017ce\u0144skim, w stosunku pokrewie\u0144stwa lub powinowactwa w linii prostej, pokrewie\u0144stwa lub powinowactwa w linii bocznej do drugiego stopnia, lub zwi\u0105zaniu z tytu\u0142u przysposobienia, opieki lub kurateli albo pozostawaniu we wsp\u00f3lnym po\u017cyciu z wykonawc\u0105, jego zast\u0119pc\u0105 prawnym lub cz\u0142onkami organ\u00f3w zarz\u0105dzaj\u0105cych lub organ\u00f3w nadzorczych wykonawc\u00f3w ubiegaj\u0105cych si\u0119 o udzielenie zam\u00f3wienia,\nc) pozostawaniu z wykonawc\u0105 w takim stosunku prawnym lub faktycznym, \u017ce istnieje uzasadniona w\u0105tpliwo\u015b\u0107 co do ich bezstronno\u015bci lub niezale\u017cno\u015bci w zwi\u0105zku z post\u0119powaniem o udzielenie zam\u00f3wienia.\nhe order cannot be awarded to entities related personally or by capital with the Ordering Party.\n\nCapital or personal connections are understood as mutual connections between the Ordering Party or persons authorized to incur obligations on behalf of the Ordering Party, or persons performing activities related to the preparation and conduct of the contractor selection procedure on behalf of the Ordering Party, and the Contractor, particularly consisting of:\nparticipating in a company as a partner in a civil partnership or partnership, holding at least 10% of shares or stocks, unless a lower threshold is stipulated by law, serving as a member of a supervisory or management body, proxy, or representative,\nbeing in a marital relationship, in a lineal kinship or affinity relationship up to the second degree, or a connection due to adoption, guardianship, or custody, cohabiting with the Contractor, their legal representative, or members of the management or supervisory bodies of Contractors applying for the contract,\nhaving a legal or factual relationship with the Contractor that raises reasonable doubts about impartiality or independence in connection with the procurement procedure.\n\nWeryfikacja nast\u0105pi w oparciu o o\u015bwiadczenie Wykonawcy o braku powi\u0105za\u0144 kapita\u0142owych i/lub osobowych, zawarte w Za\u0142\u0105czniku nr 1 \u201cFormularz ofertowy\u201d.\nVerification will be based on the Contractor's statement of no capital and/or personal ties, included in Appendix  No. 1 \"Proposal Form\".\n\n2. Zam\u00f3wienie nie mo\u017ce zosta\u0107 udzielone w sytuacji wyst\u0105pienia konfliktu interes\u00f3w, z naruszeniem r\u00f3wnego traktowania wykonawc\u00f3w lub w spos\u00f3b prowadz\u0105cy do zak\u0142\u00f3cenia konkurencji. Zgodnie z definicj\u0105 wskazan\u0105 w \"Wytycznych dotycz\u0105cych kwalifikowalno\u015bci wydatk\u00f3w na lata 2021-2027\" konflikt interes\u00f3w oznacza ka\u017cd\u0105 sytuacj\u0119, w kt\u00f3rej osoby bior\u0105ce udzia\u0142 w przygotowaniu lub prowadzeniu post\u0119powania o udzielenie zam\u00f3wienia lub mog\u0105ce wp\u0142yn\u0105\u0107 na wynik tego post\u0119powania maj\u0105, bezpo\u015brednio lub po\u015brednio, interes finansowy, ekonomiczny lub inny interes osobisty, kt\u00f3ry postrzega\u0107 mo\u017cna jako zagra\u017caj\u0105cy ich bezstronno\u015bci i niezale\u017cno\u015bci w zwi\u0105zku z post\u0119powaniem o udzielenie zam\u00f3wienia\u201d.\nThe contract may not be awarded in a situation of conflict of interests, in breach of the equal treatment of contractors or in a way that leads to distortion of competition. According to the definition given in the \"Guidelines on the eligibility of expenditure for the years 2021-2027\",  a conflict of interests means any situation in which persons involved in the preparation or conduct of the procurement procedure or who may influence the outcome of this procedure have, directly or indirectly, a financial, economic or other personal interest that may be perceived as compromising their impartiality and independence in connection with the procurement procedure.\n3. Wykluczeniu z post\u0119powania podlegaj\u0105 Wykonawcy, kt\u00f3rych oferty s\u0105 niekompletne i nie zawieraj\u0105 dokument\u00f3w i o\u015bwiadcze\u0144 wymaganych zgodnie z pkt III i IV zapytania ofertowego.\nContractors whose offers are incomplete and do not contain statements required in points III and IV are subject to exclusion from the procedure.\n4. Z udzia\u0142u w post\u0119powaniu wykluczone s\u0105 r\u00f3wnie\u017c podmioty, w stosunku do kt\u00f3rych zachodz\u0105 okoliczno\u015bci opisane w art. 7 ust. 1 ustawy z dnia 13 kwietnia 2022 r.  o szczeg\u00f3lnych rozwi\u0105zaniach w zakresie przeciwdzia\u0142ania wspieraniu agresji na Ukrain\u0119 oraz s\u0142u\u017c\u0105cych ochronie bezpiecze\u0144stwa narodowego\nEntities are also excluded from participation in the proceedings if the circumstances apply as defined under Article 7 section 1 of the Act of 13 April 2022 on special solutions to prevent support for the aggression against Ukraine and to protect national security.\n\nWeryfikacja nast\u0105pi w oparciu o o\u015bwiadczenie Wykonawcy, zawarte w Za\u0142\u0105czniku nr 1 \u201cFormularz ofertowy\u201d.\nVerification will be based on the Contractor's statement,  included in Appendix  No. 1 \"Proposal Form\".","type":{"id":7,"name":"Dodatkowe warunki udzia\u0142u"},"created_by":null,"created_at":"2025-12-04 12:30:31","modified_at":"2025-12-23 12:04:08","modified_by":null,"group_uuid":"78588515-bf8f-4fdd-8b36-d1f7542c7b1a"},{"id":1757252,"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. 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