Contract award notice
Results of the procurement procedure
Section I: Contracting
entity
I.1) Name and addresses
NHS South West — Acutes
1234
Acute Trusts, South West region
Torquay
UK
Contact person: Louise Rowe
Telephone: +44 1803660069
E-mail: louise.rowe3@nhs.net
NUTS: UKK42
Internet address(es)
Main address: http://www.torbaypharmaceuticals.nhs.uk/
I.2) Joint procurement
The contract is awarded by a central purchasing body
I.4) Type of the contracting authority
Regional or local authority
I.5) Main activity
Health
Section II: Object
II.1) Scope of the procurement
II.1.1) Title
Regulatory Consulting Services Framework
II.1.2) Main CPV code
73000000
II.1.3) Type of contract
Services
II.1.4) Short description
One of the main strategic business aims of Torbay Pharmaceuticals is to increase the number of licensed products held by TP. To support this strategy a programme of products for licensing (which are currently manufactured by TP) has been created. Individual projects will be outsourced to regulatory consultants to project manage the generation of a MAA for filing into the regulatory agencies identified from the regulatory strategy for the individual product.
II.1.6) Information about lots
This contract is divided into lots:
Yes
II.2) Description
Lot No: 1
II.2.1) Title
Regulatory Consulting Services Framework
II.2.2) Additional CPV code(s)
73200000
73220000
II.2.3) Place of performance
NUTS code:
UKK42
UKK4
UKK
UK
II.2.4) Description of the procurement
Author a CMC Module 3 and Module 2.3 Quality Overall Summary (the majority of the 3.2.S and 2.3.S sections will consist of an ASMF or CEP as supplied by TP).
II.2.5) Award criteria
Price
II.2.11) Information about options
Options:
No
II.2.13) Information about European Union funds
The procurement is related to a project and/or programme financed by European Union funds:
No
Lot No: 2
II.2.1) Title
Author a CMC Module 3 and Module 2.3 Quality Overall Summary (the Majority of the 3.2.S and 2.3.S)
II.2.2) Additional CPV code(s)
73200000
73220000
II.2.3) Place of performance
NUTS code:
UKK42
UKK4
UKK
UK
II.2.4) Description of the procurement
Author a CMC Module 3 and Module 2.3 Quality Overall Summary (the majority of the 3.2.S and 2.3.S sections will consist of an ASMF or CEP as Supplied by TP).
II.2.5) Award criteria
Price
II.2.11) Information about options
Options:
No
II.2.13) Information about European Union funds
The procurement is related to a project and/or programme financed by European Union funds:
No
Lot No: 3
II.2.1) Title
Author a Non-Clinical Module 4 and Module 2.4 and 2.6 Non-Clinical Overview and Summary including the EU
II.2.2) Additional CPV code(s)
73200000
73220000
II.2.3) Place of performance
NUTS code:
UKK42
UKK4
UKK
UK
II.2.4) Description of the procurement
Author a CMC Module 3 and Module 2.3 Quality Overall Summary (the majority of the 3.2.S and 2.3.S sections will consist of an ASMF or CEP as supplied by TP).
II.2.5) Award criteria
Price
II.2.11) Information about options
Options:
No
II.2.13) Information about European Union funds
The procurement is related to a project and/or programme financed by European Union funds:
No
Lot No: 4
II.2.1) Title
Author a Clinical Module 5 and Module 2.5 and 2.7 Clinical Overview and Summary including the EU based s
II.2.2) Additional CPV code(s)
73200000
73220000
II.2.3) Place of performance
NUTS code:
UKK42
UKK4
UKK
UK
II.2.4) Description of the procurement
Author a CMC Module 3 and Module 2.3 Quality Overall Summary (the majority of the 3.2.S and 2.3.S sections will consist of an ASMF or CEP as supplied by TP).
II.2.5) Award criteria
Price
II.2.11) Information about options
Options:
No
II.2.13) Information about European Union funds
The procurement is related to a project and/or programme financed by European Union funds:
No
Lot No: 5
II.2.1) Title
Author a CTD Module 1 including RMP, SPC/PIL and Annexes
II.2.2) Additional CPV code(s)
73200000
73220000
II.2.3) Place of performance
NUTS code:
UKK42
UKK4
UKK
UK
II.2.4) Description of the procurement
Author a CMC Module 3 and Module 2.3 Quality Overall Summary (the majority of the 3.2.S and 2.3.S sections will consist of an ASMF or CEP as supplied by TP).
II.2.5) Award criteria
Price
II.2.11) Information about options
Options:
No
II.2.13) Information about European Union funds
The procurement is related to a project and/or programme financed by European Union funds:
No
Section IV: Procedure
IV.1) Description
IV.1.1) Type of procedure
Open procedure
IV.1.3) Information about a framework agreement or a dynamic purchasing system
The procurement involves the establishment of a framework agreement
IV.1.8) Information about Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement:
No
IV.2) Administrative information
IV.2.1) Previous publication concerning this procedure
Notice number in the OJ S:
2018/S 147-336785
IV.2.9) Information about termination of call for competition in the form of a prior information notice
The contracting authority will not award any further contracts based on the above prior information notice
Section V: Award of contract
Contract No: 1
Title: Regulatory Consulting Services Framework
A contract/lot is awarded:
No
V.1 Information on non-award
The contract/lot is not awarded
Other reasons (discontinuation of procedure)
Section V: Award of contract
Contract No: 2
Title: Author a CMC Module 3 and Module 2.3 Quality Overall Summary (the majority of the 3.2.S and 2.3.S
A contract/lot is awarded:
No
V.1 Information on non-award
The contract/lot is not awarded
Other reasons (discontinuation of procedure)
Section V: Award of contract
Contract No: 3
Title: Author a Non-Clinical Module 4 and Module 2.4 and 2.6 Non-Clinical Overview and Summary including the EU
A contract/lot is awarded:
No
V.1 Information on non-award
The contract/lot is not awarded
Other reasons (discontinuation of procedure)
Section V: Award of contract
Contract No: 4
Title: Author a Clinical Module 5 and Module 2.5 and 2.7 Clinical Overview and Summary including the EU based s
A contract/lot is awarded:
No
V.1 Information on non-award
The contract/lot is not awarded
Other reasons (discontinuation of procedure)
Section V: Award of contract
Contract No: 5
Title: Author a CTD Module 1 including RMP, SPC/PIL and Annexes
A contract/lot is awarded:
No
V.1 Information on non-award
The contract/lot is not awarded
Other reasons (discontinuation of procedure)
Section VI: Complementary information
VI.4) Procedures for review
VI.5) Date of dispatch of this notice
19/08/2019