Summary
- Profile Type
- Business request
- POD Reference
- BRGB20250620016
- Term of Validity
- 20 June 2025 - 20 June 2026
- Company's Country
- United Kingdom
- Type of partnership
- Commercial agreement
- Targeted Countries
- All countries
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General information
- Short Summary
- A UK-based SME pharmaceutical company is seeking to in-license innovative or established medicines that are already approved or near-market outside the UK or outside the EU/EEA. The company is seeking to expand its portfolio of licensed medicines through in-licensing partnerships and offers a full-service regulatory, quality, reimbursement, market access, and commercialisation pathway for rapid entry into the UK and EU markets.
- Full Description
-
A UK SME pharmaceutical company with proven expertise in regulatory adaptation, market access, and commercial launch is seeking to expand its portfolio of licensed medicines through in-licensing partnerships. The company focuses on products that have already received approval or are nearing the market in their home countries, specifically the EU, EEA, Australia, Canada, Japan, New Zealand, Switzerland, and the USA. These products are suitable for adaptation to the UK regulatory environment.
The company provides a comprehensive, low-risk pathway for overseas partners to access the UK’s single-payer NHS system and benefit from its pricing model and clear reimbursement mechanisms of the NHS. The process includes strategic planning, regulatory dossier adaptation, submission to the Medicines and Healthcare Products Regulatory Agency (MHRA), and, once approved, pricing, commercial launch, sales & marketing and distribution in the UK. The company also offers the opportunity to extend authorisation to the EU using the same regulatory dossier.
This approach removes the necessity for partners to set up their own UK infrastructure, thereby reducing costs and time-to-market while ensuring compliance and maximising commercial potential. The company utilises an established network of consultants, CROs, and market access experts to optimise every stage of the process. - Advantages and Innovations
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The partner will benefit from new revenue streams and market access without needing to establish local infrastructure.
• Full-service regulatory and commercialisation support
• No need for partner to set up local UK operations
• Access to NHS and EU markets
• Deep local knowledge and networks
• Experienced in both commercial and supply chain - Technical Specification or Expertise Sought
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The potential partner should meet the following criteria:
- Medicine Approval: The partner must have an approved or near-market medicine in their home country.
- Regulatory Dossier: A complete regulatory dossier should be ready for adaptation.
- Licensing and Commercial Rights: The partner is expected to grant licensing or commercial rights for the product’s registration and commercialization in the UK, with potential expansion into the EU.
- Documentation Access: The partner will provide access to regulatory, clinical, and quality documentation.
- Support: The partner may offer technical or scientific support as needed.
The goal is to achieve rapid, low-risk market entry in the UK, leveraging the UK SME’s regulatory and commercial expertise, with potential expansion into the EU and other countries.
The partner benefits from new revenue streams and market access without needing to establish local infrastructure. - Stage of Development
- Already on the market
- Sustainable Development Goals
- Goal 3: Good Health and Well-being
Partner Sought
- Expected Role of a Partner
-
Type of partner sought:
The UK company is seeking to partner with SME or mid-sized pharmaceutical, healthcare and biotechnology companies based in the EU, EEA, Australia, Canada, Japan, New Zealand, Switzerland, or the USA, with an established presence in their home market.
The partner should hold an approved or near-market medicine in their home country, with a complete regulatory dossier ready for adaptation.
The partner is expected to grant licensing or commercial rights for the product’s registration and commercialisation in the UK (and potentially the EU).
The partner will provide access to regulatory, clinical, and quality documentation, and may offer technical or scientific support as needed.
The goal is to help the partner achieve rapid, low-risk market entry in the UK, utilising the UK company's regulatory and commercial expertise, followed by potential expansion into the EU.
The partner will benefit from new revenue streams and market access without needing to establish local infrastructure. - Type and Size of Partner
- SME <=10
- Big company
- SME 50 - 249
- SME 11-49
- R&D Institution
- Type of partnership
- Commercial agreement
Dissemination
- Market keywords
- 05007007 - Other medical/health related (not elsewhere classified)
- 05005022 - Other clinical medicine
- 05005003 - Endocrinology
- 05005004 - Gastroenterology
- Sector Groups Involved
- Health
- Targeted countries
- All countries