{"status":"OK","data":{"advertisement":{"id":224977,"title":"Nr PB003/PB004/04/2023\n\u201ePrzygotowanie 2 aplikacji eIND (exploratory investigational new drug) w formacie eCTD oraz ich z\u0142o\u017cenie do FDA\u201d\n\"Compilation of 2 eIND (exploratory investigational new drug) applications in the eCTD format and their submission to FDA\"","partial_offer_allowed":false,"publication_date":"2023-08-29","submission_deadline":"2023-09-28 23:59:59","planned_sign_date":"2023-09-01","supplementary_orders":"-","terms_of_contract_change":null,"created_at":"2023-08-29 15:38:21","modified_at":"2023-09-29 00:00:03","contact_persons":[{"id":3163,"forename":"Karolina","surname":"Miernik","phone_number":"","email":"k.miernik@purebiologics.com","created_by":null,"created_at":"2023-12-05 14:42:15","modified_at":"2023-12-05 14:42:15","modified_by":null}],"orders":[{"id":368436,"estimated_value":null,"order_items":[{"id":416504,"description":"Numer: PB003/PB004/04/2023\nPrzedmiotem zam\u00f3wienia jest us\u0142uga polegaj\u0105ca na przygotowaniu 2 aplikacji eIND (exploratory investigational new drug) w formacie eCTD (electronic common techincal document) oraz ich z\u0142o\u017cenie do FDA (Food and Drug Administration)- po jednej aplikacji dla ka\u017cdego z dw\u00f3ch przedmiotowych projekt\u00f3w, w tym na:\n-\tweryfikacji zgodno\u015bci dostarczonych przez Pure Biologics S.A. dokument\u00f3w z wytycznymi FDA i wymogami formatu eCTD,\n-\tdzia\u0142aniach zwi\u0105zanych z formatowaniem dokumentacji i/lub dora\u017ane doradztwo regulacyjne w wymiarze nie wi\u0119kszym ni\u017c 10 godzin,\n-\twyst\u0105pienie o nadanie numer\u00f3w IND dla dw\u00f3ch aplikacji,\n-\tstworzeniu elektronicznych wersji wniosk\u00f3w wraz z ca\u0142\u0105 niezb\u0119dn\u0105 dokumentacj\u0105 (w formacie CTD) o wydanie zgody na przeprowadzenie badania klinicznego na podstawie dokumentacji dostarczonej przez Pure Biologics S.A.,\n-\thyperlinkingu aplikacji oraz kontrola jako\u015bci wniosku,\n-\tdzia\u0142aniu jako ameryka\u0144ski przedstawiciel Pure Biologics S.A. do kontakt\u00f3w z FDA,\n-\tprowadzenie komunikacji z FDA w przypadku uwag lub pyta\u0144 do wniosk\u00f3w ze strony FDA. \n\nThe subject of the contract is a service consisting in the preparation of 2 eIND (exploratory investigational new drug) applications in the eCTD format and their submission to FDA - one application for each of the two projects in question, including:\n- verification of the submission-readiness of the documents provided by Pure Biologics and their compliance with the FDA guidelines,\n- activity on the formatting of the documents and/or ad hoc regulatory support up to 10 working hours,\n- request for IND numbers for the two applications,\n- applications compilation in the eCTD format based on the documentation provided by Pure Biologics and   their submission to FDA,\n- application hyperlinking and application quality control,\n- acting as the US representative of Pure Biologics for contacts with the FDA,\n- communication with FDA on behalf of Pure Biologics in case of comments or questions regarding the applications.\n","warranty_period":null,"cpv_items":[{"id":8514,"code":"73110000-6","name":"Us\u0142ugi badawcze"}],"timetable_items":[],"fulfillment_places":[{"country":"Polska","voivodeship":"dolno\u015bl\u0105skie","poviat":"Wroc\u0142aw","commune":"Wroc\u0142aw-Fabryczna","locality":"Wroc\u0142aw","created_by":null,"created_at":"2023-08-29 15:38:21","modified_at":"2023-08-29 15:38:21","modified_by":null,"id":467772,"type":{"id":1,"name":"adres"},"group_uuid":"8fbf1206-6121-4455-aee7-622b1418d14b"}],"participation_conditions":[{"id":1137211,"description":"1.\tZamawiaj\u0105cy zastrzega, \u017ce oferty mog\u0105 z\u0142o\u017cy\u0107 wy\u0142\u0105cznie Oferenci, kt\u00f3rzy:\na.\tposiadaj\u0105 uprawnienia do wykonywania okre\u015blonej dzia\u0142alno\u015bci lub czynno\u015bci, je\u017celi przepisy prawa nak\u0142adaj\u0105 obowi\u0105zek ich posiadania do wykonywania dzia\u0142alno\u015bci obj\u0119tej zam\u00f3wieniem,\nb.\tdysponuj\u0105 personelem o kwalifikacjach pozwalaj\u0105cych na wykonanie zam\u00f3wienia,  w tym osobami z bieg\u0142\u0105 znajomo\u015bci\u0105 wytycznych FDA dotycz\u0105cych sk\u0142adania wniosk\u00f3w o wydanie zgody na przeprowadzenie badania klinicznego, potwierdzonych z\u0142o\u017ceniem 10 wniosk\u00f3w  IND, w tym min. 3 eIND do FDA w ci\u0105gu ostatnich 5 lat\nc.\tposiadaj\u0105 mo\u017cliwo\u015bci techniczne do wykonania wszystkich czynno\u015bci wymienionych w niniejszym zam\u00f3wieniu,\nd.\tna \u017cyczenie Zamawiaj\u0105cego przed podpisaniem umowy przedstawi\u0105 odpowiednie dokumenty  potwierdzaj\u0105ce spe\u0142nianie wymaga\u0144 dotycz\u0105cych Oferent\u00f3w,\n\n1.\tThe Ordering Party reserves that tenders may be submitted only by Bidders who:\na.\thave the authorization to perform a specific activity or action, if the provisions of law impose an obligation to hold them to perform the activity covered by the contract;\nb.\thave staff with qualifications allowing them to perform the order, including persons proficient in FDA application guidelines for consent to conduct a clinical trial, confirmed by 10 IND submissions, including min. 3 eIND submissions to the FDA in the last 5 years;\nc.\thave the technical capabilities to perform all the activities listed in this order;\nd.\tat the request of the Ordering Party, before signing the contract, they will present the relevant documents confirming the fulfillment of the requirements for Bidders.","type":{"id":4,"name":"Osoby zdolne do wykonania zam\u00f3wienia"},"created_by":null,"created_at":"2023-08-29 15:38:21","modified_at":"2023-08-29 15:38:21","modified_by":null,"group_uuid":"5b3da2ed-2bb3-457b-907c-c16eecb99125"},{"id":1137212,"description":"Oferta powinna zawiera\u0107 podpisane przez osoby upowa\u017cnione za\u0142\u0105czniki, przynajmniej:\na.\tdokument upowa\u017cniaj\u0105cy/upowa\u017cnienie dla osoby sk\u0142adaj\u0105cej ofert\u0119,\nb.\tza\u0142\u0105cznik nr 1 - uzupe\u0142niony formularz oferty wraz z o\u015bwiadczeniami dotycz\u0105cymi Oferenta, \nc.\tza\u0142\u0105cznik nr 2 - o\u015bwiadczenie o braku powi\u0105za\u0144 pomi\u0119dzy podmiotami wsp\u00f3\u0142pracuj\u0105cymi.\nDopuszczalne jest podpisanie i z\u0142o\u017cenie oferty w formie elektronicznej.\n\nThe offer should contain attachments signed by authorized persons, at least:\na.\tdocument authorizing/authorization for the person submitting the offer,\nb.\tAttachment No. 1 \u2013 completed tender form together with statements concerning the Bidder,\nc.\tAttachment No. 2 - statement on the lack of relations between cooperating entities.\n It is acceptable to sign and submit the offer electronically.","type":{"id":6,"name":"Lista wymaganych dokument\u00f3w/o\u015bwiadcze\u0144"},"created_by":null,"created_at":"2023-08-29 15:38:21","modified_at":"2023-08-29 15:38:21","modified_by":null,"group_uuid":"1651141e-338b-4926-8814-439ba6443cef"},{"id":1137213,"description":"Nie dopuszcza si\u0119 z\u0142o\u017cenia oferty cz\u0119\u015bciowej.\nNie dopuszcza si\u0119 z\u0142o\u017cenia oferty wariantowej.\nTermin zwi\u0105zania ofert\u0105 wynosi: 60 dni od daty okre\u015blonej w II.4.4.p.1.\n\nThe possibility of submitting a partial bid is not admissible.\nThe possibility of submitting a variant bid is not admissible.\nThe binding period with the bid: 60 days from the date specified in II.4.4. p.1.","type":{"id":7,"name":"Dodatkowe warunki udzia\u0142u"},"created_by":null,"created_at":"2023-08-29 15:38:21","modified_at":"2023-08-29 15:38:21","modified_by":null,"group_uuid":"75ec9604-d0ac-4539-914a-1e511ce21842"}],"category":{"id":1,"name":"Us\u0142uga"},"subcategory":{"id":8,"name":"Us\u0142ugi inne"},"created_by":null,"created_at":"2023-08-29 15:38:21","modified_at":"2023-08-29 15:38:21","modified_by":null,"group_uuid":"c975cf57-3f00-48fa-b20e-a86f54525206"}],"evaluation_criteria":[{"id":634475,"price_criterion":true,"description":"Cena-100%\nPrice-100%","created_by":null,"created_at":"2023-08-29 15:38:21","modified_at":"2023-08-29 15:38:21","modified_by":null,"group_uuid":"64278616-7d22-44dd-9886-1a31e5c2127c"}],"is_variant":false,"title":"Us\u0142uga/ Service","order_node":{"id":280011},"created_by":null,"created_at":"2023-08-29 15:38:21","modified_at":"2023-08-29 15:38:21","modified_by":null}],"created_by":{"id":95,"contact_persons":[]},"modified_by":{"modified_by":null,"id":1,"contact_persons":[]},"status":{"id":2,"label":"PUBLISHED","name":"Opublikowane"},"advertiser_address_details":{"name":"Pure Biologics S.A.","identification_number_type":"nip","identification_number":"8943003192","address":{"country":"Polska","voivodeship":"dolno\u015bl\u0105skie","poviat":"Wroc\u0142aw","commune":"Wroc\u0142aw-Fabryczna","locality":"Wroc\u0142aw","created_by":{"id":95,"contact_persons":[]},"created_at":"2023-08-29 15:38:21","modified_at":"2023-08-29 15:38:21","modified_by":{"id":95,"contact_persons":[]},"id":590625,"street":"Du\u0144ska","number_description":"11","postcode":"54-427"},"created_by":{"id":95,"contact_persons":[]},"created_at":"2023-08-29 15:38:21","modified_at":"2023-08-29 15:38:21","modified_by":{"id":95,"contact_persons":[]},"id":225475},"advertisement":{"id":171452,"number":"2023-95-171452","publication_date":"2023-08-29","created_by":{"id":95,"contact_persons":[]},"created_at":"2023-08-29 15:34:05","modified_at":"2023-09-29 00:00:03","modified_by":{"modified_by":null,"id":1,"contact_persons":[]},"status":{"id":6,"label":"RESOLVED","name":"Rozstrzygni\u0119te"},"all_available_version_ids":[224975,224976,224977],"enrollment":null,"projects":[{"id":16222,"name":"Opracowanie bispecyficznego fragmentu przeciwcia\u0142a do symultanicznego zwalczania nowotworu i rekrutacji kom\u00f3rek uk\u0142adu immunologicznego (BIKE)","number":"0209/19","activity":{"created_by":{"modified_by":null,"id":1,"contact_persons":[]},"created_at":"2020-08-17 19:00:00","modified_at":"2020-08-17 19:00:00","modified_by":{"modified_by":null,"id":1,"contact_persons":[]}},"region":{"created_by":{"modified_by":null,"id":1,"contact_persons":[]},"created_at":"2022-02-10 21:45:42","modified_at":"2022-02-10 21:45:42","modified_by":{"modified_by":null,"id":1,"contact_persons":[]}},"institution":null,"full_number":"POIR.01.01.01-00-0209/19","perspective":{},"programme":{"created_by":{"modified_by":null,"id":1,"contact_persons":[]},"created_at":"2020-08-17 19:00:00","modified_at":"2020-08-17 19:00:00","modified_by":{"modified_by":null,"id":1,"contact_persons":[]}},"priority":{"created_by":{"modified_by":null,"id":1,"contact_persons":[]},"created_at":"2020-08-17 19:00:00","modified_at":"2020-08-17 19:00:00","modified_by":{"modified_by":null,"id":1,"contact_persons":[]}},"type":"project","created_by":{"id":95,"contact_persons":[]},"created_at":"2021-04-09 17:47:11","modified_at":"2021-04-09 17:47:11","modified_by":{"id":95,"contact_persons":[]}},{"id":35947,"name":"\u201eUs\u0142uga produkcji i oczyszczania rekombinowanych ludzkich przeciwcia\u0142 monospecyficznych oraz bispecyficznych.\u201d","number":"0086/18","activity":{"created_by":{"modified_by":null,"id":1,"contact_persons":[]},"created_at":"2020-08-17 19:00:00","modified_at":"2020-08-17 19:00:00","modified_by":{"modified_by":null,"id":1,"contact_persons":[]}},"region":{"created_by":{"modified_by":null,"id":1,"contact_persons":[]},"created_at":"2022-02-10 21:45:42","modified_at":"2022-02-10 21:45:42","modified_by":{"modified_by":null,"id":1,"contact_persons":[]}},"institution":null,"full_number":"POIR.01.02.00-02-0086/18","perspective":{},"programme":{"created_by":{"modified_by":null,"id":1,"contact_persons":[]},"created_at":"2020-08-17 19:00:00","modified_at":"2020-08-17 19:00:00","modified_by":{"modified_by":null,"id":1,"contact_persons":[]}},"priority":{"created_by":{"modified_by":null,"id":1,"contact_persons":[]},"created_at":"2020-08-17 19:00:00","modified_at":"2020-08-17 19:00:00","modified_by":{"modified_by":null,"id":1,"contact_persons":[]}},"type":"project","created_by":{"id":95,"contact_persons":[]},"created_at":"2023-03-02 16:52:20","modified_at":"2023-03-02 16:52:20","modified_by":{"id":95,"contact_persons":[]}}],"is_author":false,"is_admin":false},"attachments":[{"origin":{"id":224975,"publication_date":"2023-08-29"},"id":1116155,"name":"Zapytanie ofertowe nr PB003/PB004/04/2023 wraz z za\u0142\u0105cznikami","file":{"id":1243800,"name":"PB003_PB004_04_2023 zapyt_ofertowe, Za\u0142.1, Za\u0142.2.pdf","created_at":"2023-08-29 15:38:21","created_by":{"forename":"Karolina","surname":"Miernik"},"uri":"/api/files/1243800"},"group_uuid":"5feb606f-0178-43fc-bf13-ec546a82bb4d"},{"origin":{"id":224975,"publication_date":"2023-08-29"},"id":1116156,"name":"Za\u0142\u0105czniki nr 1 i 2 do zapytania ofertowego nr PB003/PB004/04/2023","file":{"id":1243803,"name":"PB003_PB004_04_2023 za\u0142\u0105czniki 1,2.docx","created_at":"2023-08-29 15:38:21","created_by":{"forename":"Karolina","surname":"Miernik"},"uri":"/api/files/1243803"},"group_uuid":"355d4c09-9a26-4149-a18f-c0260b080160"},{"origin":{"id":224975,"publication_date":"2023-08-29"},"id":1116157,"name":"Request for a Tender no. PB003/PB004/04/2023 with attachments","file":{"id":1243805,"name":"PB003_PB004_04_2023 Request for a tender plus attachments.pdf","created_at":"2023-08-29 15:38:21","created_by":{"forename":"Karolina","surname":"Miernik"},"uri":"/api/files/1243805"},"group_uuid":"d48ca0ee-6afc-4b5d-98f2-d08a48ca159b"},{"origin":{"id":224975,"publication_date":"2023-08-29"},"id":1116158,"name":"Attachments 1 and 2 to Request for a Tender no. PB003/PB004/04/2023","file":{"id":1243807,"name":"PB003_PB004_04_2023 Attachments 1,2.docx","created_at":"2023-08-29 15:38:21","created_by":{"forename":"Karolina","surname":"Miernik"},"uri":"/api/files/1243807"},"group_uuid":"1a050c1e-4971-4596-a98c-77563970ad14"}]},"dictionaries":{"announcement_status_draft":1,"announcement_status_published":2},"favorite":null,"badge":null,"offer_set_badge_count":null,"question_badge_count":null}}