{"status":"OK","data":{"advertisement":{"id":389046,"title":"ZAPYTANIE OFERTOWE LERCAN/6/PR 138141/2026-90231-293537 Zakup us\u0142ugi bada\u0144 bior\u00f3wnowa\u017cno\u015bci w celu por\u00f3wnania biodost\u0119pno\u015bci oraz oceny bezpiecze\u0144stwa i tolerancji Produktu Testowanego z Produktem Referencyjnym u zdrowych ochotnik\u00f3w.\n\n\nOFFER INQUIRY LERCAN/6/PR 138141/ 2026-90231-293537  Purchase of a bioequivalence study service aimed at comparing bioavailability and assessing the safety and tolerability of the Test Product versus the Reference Product in healthy volunteers.","partial_offer_allowed":false,"publication_date":"2026-10-01","submission_deadline":"2026-11-02 23:59:59","planned_sign_date":"2026-12-01","supplementary_orders":null,"terms_of_contract_change":"Szczeg\u00f3\u0142owe informacje znajduj\u0105 si\u0119 w punkcie XIII za\u0142\u0105czonego Zapytania ofertowego.\n\nThe detailed information can be found in Section XIII of the attached Request for Quotation.","created_at":"2026-10-01 14:22:48","modified_at":"2026-10-01 17:11:28","contact_persons":[{"id":88882,"forename":"Beata","surname":"\u017bywicka","phone_number":"","email":"beata.zywicka@polpharma.com","created_by":null,"created_at":"2026-10-01 14:22:48","modified_at":"2026-10-01 14:22:48","modified_by":null}],"orders":[{"id":630283,"estimated_value":null,"order_items":[{"id":708808,"description":"ZAPYTANIE OFERTOWE LERCAN/6/PR 138141/ 2026-90231-293537 na zakup us\u0142ugi bada\u0144 bior\u00f3wnowa\u017cno\u015bci w celu por\u00f3wnania biodost\u0119pno\u015bci oraz oceny bezpiecze\u0144stwa i tolerancji Produktu Testowanego z Produktem Referencyjnym u zdrowych ochotnik\u00f3w. 3.5.\t\nSzczeg\u00f3\u0142owy opis przedmiotu zam\u00f3wienia okre\u015blony w ZA\u0141\u0104CZNIKU NR 2 jest obj\u0119ty ochron\u0105 tajemnicy przedsi\u0119biorstwa w rozumieniu przepis\u00f3w ustawy z dnia 16 kwietnia 1993 r. o zwalczaniu nieuczciwej konkurencji (Dz. U. z 2022 r. poz. 1233, z p\u00f3\u017an. zm.) i jego przekazanie wymaga zawarcia stosownej umowy o zachowaniu poufno\u015bci (ang. Non-Disclosure Agreement, NDA), stanowi\u0105cej ZA\u0141\u0104CZNIK NR 3 do niniejszego zapytania ofertowego. \n\nOFFER INQUIRY LERCAN/6/PR 138141/2026-90231-293537  for the purchase of a bioequivalence study service aimed at comparing bioavailability and assessing the safety and tolerability of the Test Product versus the Reference Product in healthy volunteers. The detailed description of the subject of the contract, specified in APPENDIX No. 2, constitutes a business secret within the meaning of the Act of 16 April 1993 on Combating Unfair Competition (Journal of Laws of 2022, item 1233, as amended).\nDisclosure of Appendix No. 2 requires execution of an appropriate Non Disclosure Agreement (NDA), constituting APPENDIX No. 3 to this Request for Quotation.","warranty_period":null,"cpv_items":[{"id":8512,"code":"73000000-2","name":"Us\u0142ugi badawcze i eksperymentalno-rozwojowe oraz pokrewne us\u0142ugi doradcze"},{"id":8517,"code":"73120000-9","name":"Us\u0142ugi eksperymentalno-rozwojowe"}],"timetable_items":[],"fulfillment_places":[{"country":"Polska","voivodeship":null,"poviat":null,"commune":null,"locality":null,"created_by":null,"created_at":"2026-10-01 14:22:48","modified_at":"2026-10-01 17:11:13","modified_by":null,"id":807793,"type":{"id":2,"name":"ca\u0142a Polska"},"group_uuid":"5bedb0e3-d655-44af-ad57-6180eff5f6f2"}],"participation_conditions":[{"id":2028686,"description":"Zamawiaj\u0105cy uzna, \u017ce Oferent spe\u0142nia niniejszy warunek, je\u017celi z\u0142o\u017cy o\u015bwiadczenie, \u017ce posiada uprawnienia niezb\u0119dne do prawid\u0142owej realizacji zam\u00f3wienia, w tym Wykonawca mo\u017ce przeprowadzi\u0107 cz\u0119\u015b\u0107 kliniczn\u0105, bioanalityczn\u0105 oraz farmakokinetyczno\u2011statystyczn\u0105 zgodnie z zasadami ICH\u2011GCP, GLP, Dyrektyw\u0105 2001/83/EC, Regulacj\u0105 (EU) 536/2014, Deklaracj\u0105 Helsi\u0144sk\u0105 oraz obowi\u0105zuj\u0105cymi europejskimi wytycznymi, w szczeg\u00f3lno\u015bci wytyczn\u0105 dotycz\u0105c\u0105 bada\u0144 bior\u00f3wnowa\u017cno\u015bci EMA/CHMP/ICH/953493/2022 (ICH M13A). Wykonawca tych cz\u0119\u015bci badania przedstawi list\u0119 inspekcji przeprowadzonych w ostatnich 10 latach (lub \u2013 w przypadku kr\u00f3tszej dzia\u0142alno\u015bci \u2013 za ca\u0142y okres funkcjonowania), wraz z podsumowaniem ich wynik\u00f3w. Przynajmniej jedna z inspekcji musi by\u0107 wykonana przez w\u0142a\u015bciwy urz\u0105d jednego z pa\u0144stw Unii Europejskiej w zakresie GCP oraz GLP. Wyniki wszystkich inspekcji z tego okresu nie mog\u0105 zawiera\u0107 niezgodno\u015bci krytycznych. Inspekcje dotycz\u0105ce bada\u0144 przeprowadzonych przed 2016 r. nie b\u0119d\u0105 uwzgl\u0119dniane.\nSpos\u00f3b weryfikacji spe\u0142niania warunk\u00f3w udzia\u0142u w post\u0119powaniu:\nWeryfikacja spe\u0142nienia warunku nast\u0105pi na podstawie o\u015bwiadczenia Oferenta zawartego w Za\u0142\u0105czniku nr 1 (Formularz ofertowy) oraz do\u0142\u0105czy do oferty list\u0119 inspekcji przeprowadzonych w ostatnich 10 lat.\n\nAuthorisation to perform specific activities or actions:\nThe Contracting Authority shall consider that the Tenderer meets this condition if the Tenderer submits a declaration confirming that it holds the authorisations required for proper performance of the contract, including that the Contractor is able to conduct the clinical, bioanalytical and pharmacokinetic\u2011statistical parts of the study in accordance with ICH\u2011GCP, GLP, Directive 2001/83/EC, Regulation (EU) 536/2014, the Declaration of Helsinki, and applicable European guidelines, in particular the bioequivalence guideline EMA/CHMP/ICH/953493/2022 (ICH M13A).\nThe Contractor performing these parts of the study shall submit a list of inspections conducted within the last 10 years (or, in the case of a shorter period of operation, for the entire period of activity), together with a summary of their outcomes.\nAt least one inspection must have been conducted by a competent authority of a European Union Member State in the scope of GCP and GLP.\nThe results of all inspections within this period must not include any critical findings.\nInspections related to studies conducted prior to 2016 shall not be taken into account.\nMethod of verification:\nVerification of compliance with this condition shall be based on the Tenderer\u2019s declaration included in Appendix No. 1 (Tender Form) and the list of inspections conducted within the last 10 years attached to the tender.","type":{"id":1,"name":"Uprawnienia do wykonywania okre\u015blonej dzia\u0142alno\u015bci lub czynno\u015bci"},"created_by":null,"created_at":"2026-10-01 14:22:48","modified_at":"2026-10-01 17:11:13","modified_by":null,"group_uuid":"5a17fbd3-ff79-4a0f-bfb1-4c6a8245d6ce"},{"id":2028687,"description":"Zamawiaj\u0105cy uzna, \u017ce Oferent spe\u0142nia niniejszy warunek, je\u017celi z\u0142o\u017cy o\u015bwiadczenie, \u017ce Wykonawca posiada do\u015bwiadczenie w prowadzeniu bada\u0144 farmakokinetycznych dla produkt\u00f3w leczniczych z\u0142o\u017conych, w tym Wykonawca na moment rozpocz\u0119cia niniejszego badania b\u0119dzie dysponowa\u0107 odpowiednim personelem, w tym wykwalifikowan\u0105 kadr\u0105 lekarsko-piel\u0119gniarsk\u0105 (z wykszta\u0142ceniem \u015brednim lub wy\u017cszym medycznym), a tak\u017ce kluczowym personelem niezb\u0119dnym do wykonania zam\u00f3wienia, w tym przynajmniej jedn\u0105 osob\u0105 na stanowisku: G\u0142\u00f3wnego Badacza, Kierownika Laboratorium Bioanalitycznego, Statystyka lub na r\u00f3wnorz\u0119dnym stanowisku. Ka\u017cda z wy\u017cej wymienionych os\u00f3b stosownie do pe\u0142nionej funkcji musi:\na)\tposiada\u0107 do\u015bwiadczenie w prowadzeniu bada\u0144 klinicznych (dla G\u0142\u00f3wnego badacza min. 5-letnie do\u015bwiadczenie oraz min. 10-letnie do\u015bwiadczenie w zawodzie lekarza, dla Statystyka min. 5-letnie do\u015bwiadczenie, dla Kierownika Laboratorium Bioanalitycznego min. 10-letnie do\u015bwiadczenie).\nb)\tposiada\u0107 wykszta\u0142cenie kierunkowe (dla G\u0142\u00f3wnego Badacza: medycyna, dla Kierownika Laboratorium Bioanalitycznego i Statystyka: medycyna, biotechnologia, farmacja, biologia, chemia, matematyka, fizyka lub pokrewne),\nc)\tposiada\u0107 umiej\u0119tno\u015b\u0107 analizy wynik\u00f3w uzyskanych w badaniu klinicznym oraz prawid\u0142owego raportowania danych z bada\u0144 zgodne z odpowiednimi procedurami i standardami.\nd)\tKryteria kwalifikacji kluczowego personelu powinny by\u0107 zawarte w odpowiednich procedurach Wykonawcy zgodnych z zasadami ICH GCP.\nSpos\u00f3b weryfikacji spe\u0142niania warunk\u00f3w udzia\u0142u w post\u0119powaniu:\nWeryfikacja spe\u0142nienia warunku nast\u0105pi na podstawie o\u015bwiadczenia Oferenta zawartego w Za\u0142\u0105czniku nr 1 (Formularz ofertowy).\n\nKnowledge and experience:\nThe Contracting Authority shall consider that the Tenderer meets this condition if the Tenderer submits a declaration confirming that the Contractor has experience in conducting pharmacokinetic studies for fixed\u2011dose combination medicinal products, and that at the time of commencement of the study the Contractor will have adequate personnel available, including qualified medical and nursing staff (with secondary or higher medical education), as well as key personnel necessary for proper performance of the contract, including at least one person in the position of: Principal Investigator, Head of the Bioanalytical Laboratory, Statistician, or an equivalent position.\nEach of the above\u2011mentioned persons, appropriate to their function, must:\na)\thave experience in conducting clinical trials (for the Principal Investigator: minimum 5 years of experience in clinical trials and at least 10 years of experience as a physician; for the Statistician: minimum 5 years of experience; for the Head of the Bioanalytical Laboratory: minimum 10 years of experience),\nb)\thold relevant education (for the Principal Investigator: medicine; for the Head of the Bioanalytical Laboratory and the Statistician: medicine, biotechnology, pharmacy, biology, chemistry, mathematics, physics or related fields),\nc)\tdemonstrate the ability to analyse clinical trial results and correctly report study data in accordance with applicable procedures and standards,\nd)\thave qualification criteria defined in the Contractor\u2019s relevant procedures compliant with ICH\u2011GCP.\n\nMethod of verification:\nVerification shall be based on the Tenderer\u2019s declaration included in Appendix No. 1 (Tender Form).","type":{"id":2,"name":"Wiedza i do\u015bwiadczenie"},"created_by":null,"created_at":"2026-10-01 14:22:48","modified_at":"2026-10-01 17:11:13","modified_by":null,"group_uuid":"9ab7c48a-2cb6-4574-9132-55e28c424950"},{"id":2028688,"description":"Zamawiaj\u0105cy uzna, \u017ce Oferent spe\u0142nia niniejszy warunek, je\u017celi z\u0142o\u017cy o\u015bwiadczenie, \u017ce dysponuje zapleczem technicznym niezb\u0119dnym do prawid\u0142owej realizacji zam\u00f3wienia, w tym Wykonawca posiada opracowan\u0105 i zwalidowan\u0105 metod\u0119 analityczn\u0105 dla wszystkich analit\u00f3w wskazanych w szczeg\u00f3\u0142owym opisaniu badania (za\u0142\u0105cznik nr 2), z odpowiednim limitem oznaczalno\u015bci, zgodnie z wymaganiami wytycznej EMA/CHMP/ICH/172948/2019 oraz ICH guideline M10 on bioanalytical method validation and study sample analysis.\n\nWykonawca ma r\u00f3wnie\u017c mo\u017cliwo\u015b\u0107 przeprowadzenia cz\u0119\u015bci klinicznej, bioanalitycznej oraz farmakokinetyczno\u2011statystycznej zgodnie z zasadami ICH\u2011GCP, GLP, Dyrektyw\u0105  2001/83/EC Regulacj\u0105 (EU) 536/2014, Deklaracj\u0105 Helsi\u0144sk\u0105 oraz obowi\u0105zuj\u0105cymi europejskimi wytycznymi, w szczeg\u00f3lno\u015bci wytyczn\u0105 dotycz\u0105c\u0105 bada\u0144 bior\u00f3wnowa\u017cno\u015bci EMA/CHMP/ICH/953493/2022 (ICH M13A).\nSpos\u00f3b weryfikacji spe\u0142niania warunk\u00f3w udzia\u0142u w post\u0119powaniu:\nWeryfikacja spe\u0142nienia warunku nast\u0105pi na podstawie o\u015bwiadczenia Oferenta zawartego w Za\u0142\u0105czniku nr 1 (Formularz ofertowy).\n\nTechnical capacity:\nThe Contracting Authority shall consider that the Tenderer meets this condition if the Tenderer submits a declaration confirming that it has the technical resources necessary for proper performance of the contract, including a developed and validated analytical method for all analytes specified in the detailed study description (Appendix No. 2), with an appropriate limit of quantification, in accordance with EMA/CHMP/ICH/172948/2019 and ICH M10 \u2013 Bioanalytical Method Validation and Study Sample Analysis.\nThe Contractor must also be capable of conducting the clinical, bioanalytical and pharmacokinetic\u2011statistical parts in compliance with ICH\u2011GCP, GLP, Directive 2001/83/EC, Regulation (EU) 536/2014, the Declaration of Helsinki, and applicable European guidelines, in particular EMA/CHMP/ICH/953493/2022 (ICH M13A).\nMethod of verification:\nVerification shall be based on the Tenderer\u2019s declaration included in Appendix No. 1 (Tender Form).","type":{"id":3,"name":"Potencja\u0142 techniczny"},"created_by":null,"created_at":"2026-10-01 14:22:48","modified_at":"2026-10-01 17:11:13","modified_by":null,"group_uuid":"3b158af8-e99f-4e00-818f-b77fd9d4afd0"},{"id":2028689,"description":"Zamawiaj\u0105cy uzna, \u017ce Oferent spe\u0142nia niniejszy warunek, je\u017celi z\u0142o\u017cy o\u015bwiadczenie, \u017ce na moment rozpocz\u0119cia niniejszego badania dysponuje zasobami ludzkimi niezb\u0119dnymi do prawid\u0142owej realizacji zam\u00f3wienia, w tym Wykonawca posiada wykwalifikowan\u0105 kadr\u0119 lekarsko-piel\u0119gniarska (z wykszta\u0142ceniem \u015brednim lub wy\u017cszym medycznym), a tak\u017ce kluczowy personel niezb\u0119dny do wykonania zam\u00f3wienia, w tym przynajmniej jedn\u0105 osob\u0105 na stanowisku: G\u0142\u00f3wnego Badacza, Kierownika Laboratorium Bioanalitycznego, Statystyka lub na r\u00f3wnorz\u0119dnym stanowisku. Ka\u017cda z wy\u017cej wymienionych os\u00f3b stosownie do pe\u0142nionej funkcji musi:\na)\tposiada\u0107 do\u015bwiadczenie w prowadzeniu bada\u0144 klinicznych (dla G\u0142\u00f3wnego badacza min. 5-letnie do\u015bwiadczenie oraz min. 10-letnie do\u015bwiadczenie w zawodzie lekarza, dla Statystyka min. 5-letnie do\u015bwiadczenie, dla Kierownika Laboratorium Bioanalitycznego min. 10-letnie do\u015bwiadczenie),\nb)\tposiada\u0107 wykszta\u0142cenie kierunkowe (dla G\u0142\u00f3wnego Badacza: medycyna, dla Kierownika Laboratorium Bioanalitycznego i Statystyka: medycyna, biotechnologia, farmacja, biologia, chemia, matematyka, fizyka lub pokrewne),\nc)\tposiada\u0107 umiej\u0119tno\u015b\u0107 analizy wynik\u00f3w uzyskanych w badaniu klinicznym oraz prawid\u0142owego raportowania danych z bada\u0144 zgodne z odpowiednimi procedurami i standardami.\nd)\tKryteria kwalifikacji kluczowego personelu powinny by\u0107 zawarte w odpowiednich procedurach Wykonawcy zgodnych z zasadami ICH GCP.\nSpos\u00f3b weryfikacji spe\u0142niania warunk\u00f3w udzia\u0142u w post\u0119powaniu:\nWeryfikacja spe\u0142nienia warunku nast\u0105pi na podstawie o\u015bwiadczenia Oferenta zawartego w Za\u0142\u0105czniku nr 1 (Formularz ofertowy).\n\nThe Contracting Authority shall consider that the Tenderer meets this condition if the Tenderer submits a declaration confirming that, at the time of commencement of the study, it has the human resources necessary for proper performance of the contract, including qualified medical and nursing staff (with secondary or higher medical education) and key personnel required for performance of the contract, including at least one person in the position of: Principal Investigator, Head of the Bioanalytical Laboratory, Statistician, or an equivalent position. Each of the above\u2011mentioned persons, appropriate to their function, must:\na)\thave experience in conducting clinical trials (for the Principal Investigator: minimum 5 years of experience in clinical trials and at least 10 years of experience as a physician; for the Statistician: minimum 5 years of experience; for the Head of the Bioanalytical Laboratory: minimum 10 years of experience),\nb)\thold relevant education (for the Principal Investigator: medicine; for the Head of the Bioanalytical Laboratory and the Statistician: medicine, biotechnology, pharmacy, biology, chemistry, mathematics, physics or related fields),\nc)\tdemonstrate the ability to analyse clinical trial results and correctly report study data in accordance with applicable procedures and standards,\nd)\thave qualification criteria defined in the Contractor\u2019s relevant procedures compliant with ICH\u2011GCP.\n\nPersons capable of performing the contract:\nMethod of verification:\nVerification shall be based on the Tenderer\u2019s declaration included in Appendix No. 1 (Tender Form).","type":{"id":4,"name":"Osoby zdolne do wykonania zam\u00f3wienia"},"created_by":null,"created_at":"2026-10-01 14:22:48","modified_at":"2026-10-01 17:11:13","modified_by":null,"group_uuid":"4d40b6f9-91dc-45fd-9ea3-56b52d9de19a"},{"id":2028690,"description":"Zamawiaj\u0105cy uzna, \u017ce Oferent spe\u0142nia niniejszy warunek, je\u017celi z\u0142o\u017cy o\u015bwiadczenie, \u017ce znajduje si\u0119 w sytuacji ekonomicznej i finansowej zapewniaj\u0105cej terminowe i zgodne z wymaganiami wykonanie przedmiotowego zam\u00f3wienia, nie znajduje si\u0119 w stanie upad\u0142o\u015bci oraz nie toczy si\u0119 w stosunku do niego post\u0119powanie likwidacyjne b\u0105d\u017a naprawcze.\nSpos\u00f3b weryfikacji spe\u0142niania warunk\u00f3w udzia\u0142u w post\u0119powaniu:\nWeryfikacja spe\u0142nienia warunku nast\u0105pi na podstawie o\u015bwiadczenia Oferenta zawartego w Za\u0142\u0105czniku nr 1 (Formularz ofertowy).\n\nEconomic or financial standing:\nThe Contracting Authority shall consider that the Tenderer meets this condition if the Tenderer submits a declaration confirming that it is in an economic and financial situation ensuring timely and compliant performance of the contract, is not bankrupt, and is not subject to liquidation or restructuring proceedings.\nMethod of verification:\nVerification shall be based on the Tenderer\u2019s declaration included in Appendix No. 1 (Tender Form).","type":{"id":5,"name":"Sytuacja ekonomiczna i finansowa"},"created_by":null,"created_at":"2026-10-01 14:22:48","modified_at":"2026-10-01 17:11:13","modified_by":null,"group_uuid":"1758793f-19c9-4ba6-87ac-8fc5284ba9d1"}],"category":{"id":1,"name":"Us\u0142uga"},"subcategory":{"id":4,"name":"Us\u0142ugi badawcze"},"created_by":null,"created_at":"2026-10-01 14:22:48","modified_at":"2026-10-01 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