Business Development Consultancy Services – 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 Africas 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),
