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.