Contract notice
Section I: Contracting
authority
I.1) Name and addresses
NHS South West - Acutes
1234
Wilkins Drive
Paignton
TQ4 7FG
UK
Contact person: Ashley Noyce
Telephone: +44 1803660040
E-mail: ashleynoyce@nhs.net
NUTS: UKK
Internet address(es)
Main address: www.torbaypharmaceuticals.nhs.uk
Address of the buyer profile: https://uk.eu-supply.com/ctm/Company/CompanyInformation/Index/45644
I.3) Communication
The procurement documents are available for unrestricted and full direct access, free of charge at:
https://uk.eu-supply.com/app/rfq/rwlentrance_s.asp?PID=27146&B=NHSSW
Additional information can be obtained from the abovementioned address
Tenders or requests to participate must be sent electronically to:
https://uk.eu-supply.com/app/rfq/rwlentrance_s.asp?PID=27146&B=NHSSW
Tenders or requests to participate must be sent to the abovementioned address
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.1.5) Estimated total value
Value excluding VAT:
200 000.00
GBP
II.1.6) Information about lots
This contract is divided into lots:
Yes
Tenders may be submitted for all lots
The contracting authority reserves the right to award contracts combining the following lots or groups of lots:
All lots.
II.2) Description
Lot No: 1
II.2.1) Title
Author a CMC Module 3
II.2.2) Additional CPV code(s)
73200000
73220000
79900000
79990000
II.2.3) Place of performance
NUTS code:
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 is not the only award criterion and all criteria are stated only in the procurement documents
II.2.7) Duration of the contract, framework agreement or dynamic purchasing system
Duration in months: 36
This contract is subject to renewal: No
II.2.9) Information about the limits on the number of candidates to be invited
II.2.10) Information about variants
Variants will be accepted:
No
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
II.2.14) Additional information
Attached as document.
Lot No: 2
II.2.1) Title
Lot 2: Author a CMC Module 3 and Module 2.3 Quality Overall Summary
II.2.2) Additional CPV code(s)
73200000
73220000
79900000
79990000
II.2.3) Place of performance
NUTS code:
UKK
II.2.4) Description of the procurement
Author a non-clinical Module 4 and Module 2.4 and 2.6 non-clinical overview and summary including the EU based signed expert statement
II.2.5) Award criteria
Price is not the only award criterion and all criteria are stated only in the procurement documents
II.2.7) Duration of the contract, framework agreement or dynamic purchasing system
Duration in months: 36
This contract is subject to renewal: No
II.2.9) Information about the limits on the number of candidates to be invited
II.2.10) Information about variants
Variants will be accepted:
No
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
II.2.14) Additional information
Attached as document.
Lot No: 3
II.2.1) Title
Lot 3: Author a Non-Clinical Module 4 and Module 2.4 and 2.6 Non-Clinical Overview and Summary
II.2.2) Additional CPV code(s)
73200000
73220000
79900000
79990000
II.2.3) Place of performance
NUTS code:
UKK
II.2.4) Description of the procurement
Author a clinical Module 5 and Module 2.5 and 2.7 clinical overview and summary including the EU based signed expert statement.
II.2.5) Award criteria
Price is not the only award criterion and all criteria are stated only in the procurement documents
II.2.7) Duration of the contract, framework agreement or dynamic purchasing system
Duration in months: 36
This contract is subject to renewal: No
II.2.9) Information about the limits on the number of candidates to be invited
II.2.10) Information about variants
Variants will be accepted:
No
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
II.2.14) Additional information
Attached as document.
Lot No: 4
II.2.1) Title
Lot 4: Author a Clinical Module 5 and Module 2.5 and 2.7 Clinical Overview
II.2.2) Additional CPV code(s)
73200000
73220000
79900000
79990000
II.2.3) Place of performance
NUTS code:
UKK
II.2.4) Description of the procurement
Author a CTD Module 1 including RMP, SPC/PIL and annexes.
II.2.5) Award criteria
Price is not the only award criterion and all criteria are stated only in the procurement documents
II.2.7) Duration of the contract, framework agreement or dynamic purchasing system
Duration in months: 36
This contract is subject to renewal: No
II.2.9) Information about the limits on the number of candidates to be invited
II.2.10) Information about variants
Variants will be accepted:
No
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
II.2.14) Additional information
Attached as document.
Lot No: 5
II.2.1) Title
Lot 5: Autjor a CTD Module 1 including RMP, SPC/PIL and Annexes
II.2.2) Additional CPV code(s)
73200000
73220000
79900000
79990000
II.2.3) Place of performance
NUTS code:
UKK
II.2.4) Description of the procurement
Author variations (Type 1A, 1B and II) to existing approved MA’s (UK, EU and global).
II.2.5) Award criteria
Price is not the only award criterion and all criteria are stated only in the procurement documents
II.2.7) Duration of the contract, framework agreement or dynamic purchasing system
Duration in months: 36
This contract is subject to renewal: No
II.2.9) Information about the limits on the number of candidates to be invited
II.2.10) Information about variants
Variants will be accepted:
No
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
II.2.14) Additional information
Attached as document.
Section III: Legal, economic, financial and technical information
III.1) Conditions for participation
III.1.2) Economic and financial standing
Selection criteria as stated in the procurement documents
III.1.3) Technical and professional ability
Selection criteria as stated in the procurement documents
III.2) Conditions related to the contract
III.2.2) Contract performance conditions
As per Tender Document and negotiated T and Cs
III.2.3) Information about staff responsible for the performance of the contract
Obligation to indicate the names and professional qualifications of the staff assigned to performing the contract
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 with several operators.
Envisaged maximum number of participants to the framework agreement: 5
IV.1.8) Information about Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement:
Yes
IV.2) Administrative information
IV.2.2) Time limit for receipt of tenders or requests to participate
Date:
01/03/2019
Local time: 12:00
IV.2.4) Languages in which tenders or requests to participate may be submitted
EN
IV.2.6) Minimum time frame during which the tenderer must maintain the tender
Tender must be valid until:
01/04/2019
IV.2.7) Conditions for opening of tenders
Date:
01/03/2019
Local time: 12:00
Place:
Torbay Pharmaceuticals, Paignton, Devon, TQ4 7FG.
Information about authorised persons and opening procedure:
Procurement Department x 2.
Section VI: Complementary information
VI.1) Information about recurrence
This is a recurrent procurement:
Yes
Estimated timing for further notices to be published:
3 years.
VI.2) Information about electronic workflows
Electronic payment will be used
VI.4) Procedures for review
VI.4.1) Review body
VI.4.2) Body responsible for mediation procedures
VI.4.4) Service from which information about the review procedure may be obtained
VI.5) Date of dispatch of this notice
31/01/2019