This RFQ seeks accredited services for the characterisation of locally produced Bevacizumab monoclonal antibody, adhering to SAHPRA and WHO guidelines. The successful bidder will ensure compliance with regulatory standards essential for biosimilarity qualification.
The Council for Scientific and Industrial Research (CSIR) is inviting quotations for the provision of accredited biosimilar characterisation services specifically for Bevacizumab, a monoclonal antibody produced locally. This tender requires expertise in biosimilarity assessments, which must align with the stringent guidelines set forth by the South African Health Products Regulatory Authority (SAHPRA) and the World Health Organization (WHO). The selected service provider will play a critical role in validating the biosimilar's quality, safety, and efficacy, ensuring that it meets all regulatory compliance requirements.
The scope of work includes comprehensive characterisation studies, analytical testing, and documentation necessary for the biosimilarity qualification process. Bidders must demonstrate their capability to conduct these assessments using accredited methodologies and provide evidence of prior experience in similar projects. The successful bidder will contribute significantly to the advancement of biopharmaceuticals in South Africa, enhancing access to effective treatments while ensuring adherence to international standards. This project not only supports local production but also fosters innovation in the healthcare sector, ultimately benefiting patients and healthcare providers alike.
This tender is suitable for businesses specializing in pharmaceutical services, particularly those with expertise in biosimilar characterisation, regulatory compliance, and analytical testing. Companies with prior experience in working with SAHPRA and WHO guidelines are encouraged to apply.
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