Universitätsklinikum TübingenTED
GMP-Produktion von Artesunat + Pyronaridin + Sulfadoxin + Pyrimethamin für klinische Studien
These specifications describe the tasks and requirements for the GMP production of a fixed dose combination of Artesunate + Pyronaridine + Sulfadoxine + Pyrimethamine for the use in a phase II - III clinical trial. Details for each individual task are listed below. All available supportive information for the conduction of the work will b...
Type: Tender
Clinical Trials
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Content at a glance
These specifications describe the tasks and requirements for the GMP production of a fixed dose combination of Artesunate + Pyronaridine + Sulfadoxine + Pyrimethamine for the use in a phase II - III clinical trial. Details for each individual task are listed below. All available supportive information for the conduction of the work wil...
- Tender type:
- Tender
- Contracting authority:
- Universitätsklinikum Tübingen
- Published:
- March 04, 2026
- Deadline:
- Not specified
- Topic:
- Clinical Trials
Tender description
These specifications describe the tasks and requirements for the GMP production of a fixed dose combination of Artesunate + Pyronaridine + Sulfadoxine + Pyrimethamine for the use in a phase II - III clinical trial. Details for each individual task are listed below. All available supportive information for the conduction of the work will be shared with the manufacturer under a non-disclosure agreement.
Further details
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Documents and attachments
49 files recorded- PDF Notice (BUL)
- PDF Notice (SPA)
- PDF Notice (CES)
- PDF Notice (DAN)
- PDF Notice (DEU)
- PDF Notice (EST)
Related tenders
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WP 1 on Output 1: The objective of this output is to improve the knowledge base among the responsible authorities on regulatory and technical aspects of integrated protected area management. - Studies for informing advancing policy instruments for the integrated management of protected areas in Viet Nam - Develop, standardise, and digitalise training curriculum on conservation finance WP2 on Output 2: The objective of this output is to strengthen protected area management boards" capacities for financial planning and management as well as to mobilise additional investment for biodiversity conservation. - Analysis of the current financial capacity, gaps and needs of the three pilot PAs in responding to their management and protection tasks and responsibilities. This will include the review and analysis of all available fundings and the efficiency in use of current financial resources applying the Protected Area Financing Self-Assessment (PAFSAT). - Develop sustainable financing "models" through plans and roadmaps for three pilot PAs including identifying potential additional sources of finance for the PA management and protection and how to mobilise/access it. A focus lies on private sector cooperation. - Coaching, training and facilitated expert exchanges during the entire assessment, planning and model implementation. This may include but is not limited to theory and practice of financial management, accounting, monitoring and reporting; fund raising, application writing and negotiation. Capacity building measures are based on PA"s needs and PA specific training plans are to be developed and implemented. - Prepare contents for the self-learning training curriculum on sustainable financing to incorporate into the digitalized training modules of the project. - Standardise reporting and accounting systems according to the requirements and regulations of donors/investors for the pilot protected area. Equip each pilot PA with an up-to-date accounting software if necessary. - Monitor and evaluate the financial management capacity as well as progress in resource mobilisation of each pilot PA by the project end to see the impact. Output 2 is outsourced in its entirety, that is the complete responsibility for delivery of results. A a comprehensive concept note is to be developped for agreement with GIZ, VNFOREST and 3 PAs. WP3 on Output 3: The objective of this output is to advance ecosystem restoration including the halting and reversing ecosystem degradation or unsustainable resource use in protected areas. This should be achieved through participatory, multi-stakeholder and cross-sectoral approaches. - Carry out study on ecosystem degradation risk / deforestation risk - Develop and test an approach for using digital tools (drones, remote sensing) for forest carbon assessment of a prevalent eco-system in the PA - Conduct eligibility and (pre-)feasibility study for a potential forest carbon project - Standardize carbon stock assessment method for the prevalent eco-system in the PA as an input to the national forest MRV. - Develop road map with options for financing to advance digital approaches to PA management WP4 on Output 4: The objective if this output is to improve the professional capacities of the administration and residents of selected protected areas for the planning and implementation of community-based, socially and environmentally compatible tourism. - Summarise good practices internationally on socially and environmentally responsible community-based tourism - Develop approach for assessing social and environmental compatibility of tourist development in PAs in Viet Nam - Assess existing trainings material and trainings on community-based tourism conducted against international best practice For the implementation of these tasks, core experts for a large part will need to deliver the services in country. The majority of work in the expert pools can be performed from their home bases; individual trips to or in Vietnam are necessary. 81322845-MAV+: Technical assistance for selected companies in the pharmaceutical sector in South Africa for the SAVax project
SAVax conducted a landscape assessment of South Africa's biopharmaceutical industry, covering the pharmaceutical, biotechnological, and biomanufacturing sectors as well as a call for applica-tions for companies to self-identify their technical assistance needs. The objective of this assignment is to engage a service provider to provide tailored technical assistance for the selected companies in the biopharmaceutical sector. This technical assistance aims at enhancing the capacities of companies to gain market access with their products. The goal is to equip these companies with the knowledge and skills necessary to advance their products to market access. The selected companies will receive targeted, non-financial support addressing the technical, regulatory, organizational, and strategic challenges they face in advancing biopharmaceutical products to market. Support areas may include, but are not limited to, the following: 1. Technology Platforms and Innovation Readiness o mRNA Technology Transfer Support: Assistance in understanding, adapting, or implementing mRNA-based platforms, including guidance on formulation, delivery systems, process design, cold-chain logistics, and regulatory considerations for mRNA therapeutics or vaccines. o Digitisation of cGMP Systems: Support in planning and implementing digital systems for Good Manufacturing Practice (GMP) compliance. This includes electronic batch records, quality management systems (QMS), equipment calibration tracking, and data integrity solutions aligned with international norms. 2. Regulatory and Quality Systems Strengthening o Navigating Regulatory Pathways: Tailored guidance for interacting with SAHPRA and other relevant authorities (e.g. WHO Prequalification), including dossier preparation, clinical trial applications, reliance mechanisms, and fast-track pathways. Also includes strategic regulatory planning for biosimilars and advanced therapies. o Quality Management Process Strengthening: Support in designing, upgrading, or implementing fit-for-purpose Quality Management Systems (QMS) based on ICH Q10 principles. This includes standard operating procedures (SOPs), change control, deviation management, and risk-based approaches to quality oversight. o ISO Certification Readiness: Technical support to prepare for ISO 9001, 13485 or other relevant certifications, including gap assessments, internal audits, documentation guidance, and quality culture development. o GMP Training and Compliance Advisory: Provision of technical training in GMP principles, inspection readiness, and facility hygiene requirements, adapted to different staff levels (operators, QA/QC, management). May include site-specific support for corrective/preventive actions (CAPA). 3. Intellectual Property and Commercial Strategy o Intellectual Property (IP) Strategies: Support in designing or refining IP strategies including freedom-to-operate analyses, IP landscaping, filing strategies (local and international), and licensing terms. Emphasis on protection in the context of part-nerships and technology transfer. o Optimising Commercialisation Pathways: Advisory services to develop and refine commercial strategies, including go-to-market models, pricing approaches, and health economic value propositions. May include support in understanding procurement systems (e.g. NHI, pooled African mechanisms). o Market Assessment and Market Access Support: Tailored market research to eval-uate demand, pricing, competition, and policy environments in local and regional markets. Support may include alignment with public procurement frameworks and donor-funded demand sources. 4. Organisational Resilience and Investment Readiness o Financial Restructuring and Strategy Advisory: Guidance on cost structures, business modelling, and capital allocation to improve organisational sustainability. Support may include preparing for audits, understanding grant or equity implications, or structuring financials for growth. o Managing Investor Relations: Capacity-building on investor engagement, including pitch deck refinement, term sheet review, investor reporting frameworks, and relationship management practices that align with sector expectations. o Mentorship Programmes: Pairing of companies with seasoned executives, technical experts, or entrepreneurs who can provide continuous coaching in technical, strategic, and commercial areas. Structured mentorship plans with KPIs will be encouraged. 5. Human Capital and Collaboration o Strategies for Talent Development and Retention: Development of internal work-force strategies including upskilling plans, career progression models, and organisational culture interventions to reduce talent attrition in critical areas like QC, regulatory affairs, and bioprocessing. o Managing Strategic Partnerships: Support in structuring and managing public-private partnerships, consortia, and technology transfer agreements. This includes due diligence, contractual frameworks, IP considerations, and governance models to ensure mutual value. o Facilitation of International Training Exchanges: Design and support of outbound and inbound staff exchange opportunities with regional or international centres of excellence, including identification of partner institutions, logistics coordination, and documentation of learning outcomes.
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