Contract Manufacturing Organisation (CMO) - Remedi4all - PR798936-3640-I

Contract Manufacturing Organisation (CMO) - Remedi4all contract manufacturing as a pharmaceutical service in the context of an open label clinical trial (monocentric openlabel study to investigate the safety, pharmacokinetics, and preliminary efficacy of oral tazarotene for the treatment of Multiple Sulfatase Deficiency (MOLTSORTAZ-MSD)) according to AMG or Regulation (EU) No. …

CPV: 33600000 Productos farmacéuticos
Plazo:
9 de diciembre de 2024 a las 11:00
Tipo de plazo:
Presentación de una oferta
Lugar de ejecución:
Contract Manufacturing Organisation (CMO) - Remedi4all - PR798936-3640-I
Organismo adjudicador:
Fraunhofer-Gesellschaft - Einkauf B12
Número de premio:
PR798936-3640-I

1. Buyer

1.1 Buyer

Official name : Fraunhofer-Gesellschaft - Einkauf B12
Legal type of the buyer : Public undertaking
Activity of the contracting authority : General public services

2. Procedure

2.1 Procedure

Title : Contract Manufacturing Organisation (CMO) - Remedi4all - PR798936-3640-I
Description : Contract Manufacturing Organisation (CMO) - Remedi4all
Procedure identifier : 69f71e99-a303-488a-bbf4-9e0a7e8a11bf
Internal identifier : PR798936-3640-I
Type of procedure : Open
The procedure is accelerated : no
Justification for the accelerated procedure :
Main features of the procedure :

2.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33600000 Pharmaceutical products

2.1.2 Place of performance

Town : Frankfurt a.M.
Postcode : 60596
Country subdivision (NUTS) : Frankfurt am Main, Kreisfreie Stadt ( DE712 )
Country : Germany

2.1.4 General information

Legal basis :
Directive 2014/24/EU
vgv -

2.1.6 Grounds for exclusion

Purely national exclusion grounds :

5. Lot

5.1 Lot technical ID : LOT-0000

Title : Contract Manufacturing Organisation (CMO) - Remedi4all - PR798936-3640-I
Description : contract manufacturing as a pharmaceutical service in the context of an open label clinical trial (monocentric openlabel study to investigate the safety, pharmacokinetics, and preliminary efficacy of oral tazarotene for the treatment of Multiple Sulfatase Deficiency (MOLTSORTAZ-MSD)) according to AMG or Regulation (EU) No. 536/2014 /GMP/GCP
Internal identifier : LOT-0000

5.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33600000 Pharmaceutical products

5.1.2 Place of performance

Town : Frankfurt a.M.
Postcode : 60596
Country subdivision (NUTS) : Frankfurt am Main, Kreisfreie Stadt ( DE712 )
Country : Germany
Additional information :

5.1.3 Estimated duration

Duration : 6 Month

5.1.6 General information

Reserved participation : Participation is not reserved.
The names and professional qualifications of the staff assigned to perform the contract must be given : Not required
Procurement Project not financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : yes

5.1.7 Strategic procurement

Aim of strategic procurement : No strategic procurement

5.1.9 Selection criteria

Criterion :
Type : Suitability to pursue the professional activity
Criterion :
Type : Economic and financial standing
Criterion :
Type : Technical and professional ability
Criterion :
Type : Other
Description : Direct link to document with suitability criteria (URL): https://vergabe.fraunhofer.de/NetServer/SelectionCriteria/54321-Tender-193062d4495-180a23782a73bca7

5.1.10 Award criteria

Criterion :
Type : Quality
Name : binding delivery time
Description : Earliest delivery date is preferred.
Weight (percentage, exact) : 40
Criterion :
Type : Price
Name : Price
Description : Total price including all additional costs and options will be evaluated.
Weight (percentage, exact) : 60
Description of the method to be used if weighting cannot be expressed by criteria :
Justification for not indicating the weighting of the award criteria :

5.1.11 Procurement documents

Languages in which the procurement documents are officially available : German

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Allowed
Address for submission : https://vergabe.fraunhofer.de
Languages in which tenders or requests to participate may be submitted : German
Electronic catalogue : Not allowed
Variants : Not allowed
Tenderers may submit more than one tender : Allowed
Deadline for receipt of tenders : 09/12/2024 11:00 +01:00
Information that can be supplemented after the submission deadline :
At the discretion of the buyer, all missing tenderer-related documents may be submitted later.
Additional information : See procurement documents
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Conditions relating to the performance of the contract : In the event that subcontractors are used, they must be named and their suitability is likewise to be substantiated on the basis of the listed documents under "Tendering terms". Furthermore, it must be confirmed that they will be available if the order is placed; their share in the scope of the contractual object must be stated.
Electronic invoicing : Allowed
Electronic ordering will be used : no
Electronic payment will be used : no
Information about review deadlines : Applications for review are not permitted if more than 15 calendar days have passed since receipt of notification from the contracting authority that it is unwilling to redress an objection (section 160 (3) sentence 1 no. 4 of the German Competition Act (Gesetz gegen Wettbewerbsbeschränkungen, GWB)). Additionally, applications for review are not permitted if an award has been made before the public procurement tribunal has informed the contracting authority about the application for review (sections 168 (2) sentence 1 and 169 (1) GWB). Contracts may be awarded 15 calendar days after the tenderer information pursuant to section 134 (1) GWB has been sent. If the information is sent electronically or by fax, the period shall be reduced to ten calendar days (section 134 (2) GWB). The period shall begin on the day after which the contracting authority sends the information; the date of receipt by the tenderer and candidate in question shall be irrelevant. The admissibility of a review application also requires that the applicant notified the contracting authority about the claimed violations of public procurement provisions within ten calendar days of becoming aware of them (section 160 (3) sentence 1 no. 1 GWB). Violations of public procurement provisions which become apparent from the tender notice must be notified to the contracting authority by the end of the time limit for the application or the submission of a tender specified in the notice (section 160 (3) sentence 1 no. 2 GWB). Violations of public procurement provisions which only become apparent from the procurement documents must be notified to the contracting authority by the end of the time limit for the application or the submission of a tender (section 160 (3) sentence 1 no. 3 GWB).

5.1.15 Techniques

Framework agreement :
No framework agreement
Information about the dynamic purchasing system :
No dynamic purchase system
Electronic auction : no

5.1.16 Further information, mediation and review

Review organisation : Vergabekammern des Bundes
Organisation providing additional information about the procurement procedure : Fraunhofer-Gesellschaft - Einkauf B12
Organisation providing more information on the review procedures : Fraunhofer Gesellschaft zur Förderung der angewandten Forschung e.V.
TED eSender : Datenservice Öffentlicher Einkauf (in Verantwortung des Beschaffungsamts des BMI)

8. Organisations

8.1 ORG-7001

Official name : Fraunhofer-Gesellschaft - Einkauf B12
Registration number : DE129515865
Postal address : Hansastraße 28
Town : München
Postcode : 80686
Country subdivision (NUTS) : München, Kreisfreie Stadt ( DE212 )
Country : Germany
Contact point : Einkauf Dienstleistungen und Energie
Telephone : +49891205-0
Roles of this organisation :
Buyer
Organisation providing additional information about the procurement procedure

8.1 ORG-7004

Official name : Vergabekammern des Bundes
Registration number : t:022894990
Postal address : Kaiser-Friedrich-Straße 16
Town : Bonn
Postcode : 53113
Country subdivision (NUTS) : Bonn, Kreisfreie Stadt ( DEA22 )
Country : Germany
Telephone : +49 228 9499-0
Roles of this organisation :
Review organisation

8.1 ORG-7005

Official name : Fraunhofer Gesellschaft zur Förderung der angewandten Forschung e.V.
Registration number : DE-129515865
Postal address : Hansastraße 27c
Town : München
Postcode : 80686
Country subdivision (NUTS) : München, Kreisfreie Stadt ( DE212 )
Country : Germany
Telephone : +49 89 1205-0
Internet address : https://www.fraunhofer.de
Roles of this organisation :
Organisation providing more information on the review procedures

8.1 ORG-7006

Official name : Datenservice Öffentlicher Einkauf (in Verantwortung des Beschaffungsamts des BMI)
Registration number : 0204:994-DOEVD-83
Town : Bonn
Postcode : 53119
Country subdivision (NUTS) : Bonn, Kreisfreie Stadt ( DEA22 )
Country : Germany
Telephone : +49228996100
Roles of this organisation :
TED eSender

11. Notice information

11.1 Notice information

Notice identifier/version : 4a8baef7-e8cf-48d1-a94b-a1e219c6a9a5 - 01
Form type : Competition
Notice type : Contract or concession notice – standard regime
Notice dispatch date : 08/11/2024 11:43 +01:00
Languages in which this notice is officially available : English

11.2 Publication information

Notice publication number : 00685134-2024
OJ S issue number : 219/2024
Publication date : 11/11/2024