Official UK procurement notice
The Development, Validation and Supply of Physostigmine Free Base
Authority: Defence Science and Technology Laboratory (Central government)
What is being bought
Published requirement descriptionThe Ministry of Defence (MoD) is inviting expressions of interest for a requirement for the provision of Physostigmine Free Base(also known as eserine; chemical name 1,2,3,3aβ,8,8aβ-hexahydro-1,3a,8-trimethylpyrrolo[2,3-b] indol-5-yl-methylcarbamate; chemical formula C15H21N3O2; molecular weight 275,36 g/mol). as part of an ongoing product development and anticipated commercialisation.
The initial Physostigmine supplied must be suitable for use in a pivotal Phase I clinical setting and the manufacturing process will produce material which does not add additional non-clinical activities to the overall programme, best endeavours should be taken to remove processing impurities.
The Supplier is to develop, scale-up and validate the manufacturing method for Physostigmine Free Base as an Active Pharmaceutical Ingredient (API) for use in a MoD final medicinal product currently under development.
The API must be developed and manufactured according to Good Manufacturing Practice (GMP) and must conform to European Transmissible Spongiform Encephalopathies (TSE) requirements, developed such that Intellectual property (IP) is vested in the Authority.
The Authority intends to seek a Marketing Authorisation for the final medicinal product from the Medicines and Healthcare products Regulatory Agency (MHRA) and Physostigmine will be required as an active ingredient for a future registered medicinal product.
The Supplier is required to provide information necessary for the Authority to complete the Chemistry, Manufacturing and Control (CMC) documentation to support a Clinical Trial Application (CTA) and Marketing Authorisation Application for the final medicinal product and make this documentation available to the MA applicant in an appropriate format for inclusion within CTD Module 3.
The Authority anticipates a Limited Quality by Design (QBD) approach to the manufacturing process as defined by the International Conference on Harmonisation (ICH).
All procurement documents are accessible via www.contracts.mod.uk ↗ Quantity or scope: The Contract has an expected duration of 10 years (120 months), plus 5 option years (60 months). Option years may be taken up consecutively or concurrently (to be determined).
CPV: Design and execution of research and development · Medicinal products for the nervous system and sensory organs · Other nervous system medicinal products · Purchase · Various medicinal products
What it takes to wini
How this buyer will score bids.
The evaluation criteria and weights exactly as published on the notice, grouped by family (price, quality, social value and so on).
Evaluation split and conditions of participation as published; the tender pack may add morei
How this buyer will score bids.
The evaluation criteria and weights exactly as published on the notice, grouped by family (price, quality, social value and so on).
- Suitability
Suppliers Instructions How to Express Interest in this Tender:
- Register your company on the eSourcing portal (this is only required once)
- Browse to the eSourcing Portal
- Click the “Click here to register” link
- Accept the terms and conditions and click “continue”
- Enter your correct business and user details
- Note the username you chose and click “Save” when complete
- You will shortly receive an email with your unique password (please keep this secure)
- Express an Interest in the tender
- Login to the portal with the username/password
- Click the "PQQs Open to All Suppliers" link. (These are Pre-Qualification Questionnaires open to any registered supplier)
- Click on the relevant PQQ to access the content.
- Click the “Express Interest” button in the “Actions” box on the left-hand side of the page.
- This will move the PQQ into your “My PQQs” page. (This is a secure area reserved for your projects only)
- Click on the PQQ code, you can now access any attachments by clicking the “Settings and Buyer Attachments” in the “Actions” box
- Responding to the tender
- You can now choose to “Reply” or “Reject” (please give a reason if rejecting)
- You can now use the ‘Messages’ function to communicate with the buyer and seek any clarification
- Note the deadline for completion, then follow the onscreen instructions to complete the PQQ
- There may be a mixture of online & offline actions for you to perform (there is detailed online help available)
If you require any furt…
- Suitability
Suppliers Instructions How to Express Interest in this Tender:
- Register your company on the eSourcing portal (this is only required once)
- Browse to the eSourcing Portal
- Click the “Click here to register” link
- Accept the terms and conditions and click “continue”
- Enter your correct business and user details
- Note the username you chose and click “Save” when complete
- You will shortly receive an email with your unique password (please keep this secure)
- Express an Interest in the tender
- Login to the portal with the username/password
- Click the "PQQs Open to All Suppliers" link. (These are Pre-Qualification Questionnaires open to any registered supplier)
- Click on the relevant PQQ to access the content.
- Click the “Express Interest” button in the “Actions” box on the left-hand side of the page.
- This will move the PQQ into your “My PQQs” page. (This is a secure area reserved for your projects only)
- Click on the PQQ code, you can now access any attachments by clicking the “Settings and Buyer Attachments” in the “Actions” box
- Responding to the tender
- You can now choose to “Reply” or “Reject” (please give a reason if rejecting)
- You can now use the ‘Messages’ function to communicate with the buyer and seek any clarification
- Note the deadline for completion, then follow the onscreen instructions to complete the PQQ
- There may be a mixture of online & offline actions for you to perform (there is detailed online help available)
If you require any furt…
- Economic & financial standing
See PQQ
- Technical & professional ability
See PQQ
- Technical & professional ability
See PQQ
- Legal form for consortia
- To be specified in the Invitation to Negotiate
- Second stage candidates
- 3–6 candidates invited to tender
- Successive reduction
- Candidates will be reduced successively across stages
Procedure terms & legal framework
From the official record · publisher note attached- Procedure method
- Negotiated
- Legal basis
- CELEX · 32009L0081 Defence and Security Public Contracts Regulations 2011 (Directive 2009/81/EC)
- Procurement category
- Goods
- Notice status
- Closed
- Procurement threshold
- Unspecified in notice
- Regulatory regime
- Standard
- Commercial structure
- Stand-alone contract (no framework)
- Competition type
- Competitive procedure
- GPA / WTO covered
- Unspecified in notice
- Recurring procurement
- Unspecified in notice
- First published
- 28 Mar 2023, 16:22 BST
- Last source update
- 28 Mar 2023, 16:22 BST
- FTS notice number
2023/S 000-009030- Classification (CPV)
- Delivery area
- Official registry OCID
ocds-h6vhtk-03b6c1Find a Tender
- Other terms
To be specified in the Invitation to Negotiate
Publisher note: The Contracting Authority intends to use an e-Tendering system in this procurement exercise, please visit www.contracts.mod.uk for full details and to register your interest in this procurement. The Cyber Risk Profile for this requirement identified by the Cyber Risk Assessment is Very Low (Reference – RAR-800645056).
How it was run
Official notice- Submission deadline
- 28 Apr 2023, 17:00 BST
- Submission channel
- {"electronicSubmission","written"}
- Accepted languages
- en
- Deposits and guarantees
- To be specified in the Invitation to Negotiate
Timeline
28 Mar 2023 → 28 Apr 2023 · 2 dates- Notice published28 Mar 2023, 16:22 BST
- Submission deadline28 Apr 2023, 17:00 BST
Contracting authority & participating public bodies
Dispute resolution & review bodies
- Defence Science and Technology LaboratoryReview body
Official documents & specifications (1)
Official links; attachments are not copiedTender pack and attachments
- Bidding documents and specifications