Expression of Interest For Medical And Pharmaceutical Value Chain

Expression Of Interest Are Invited For Medical And Pharmaceutical Value Chain In The Sadc Region. Closing Date: April 13, 2023 The Southern African Development Community (Sadc) Secretariat, The European Union (Eu) And The German Federal Ministry For Economic Cooperation And Development (Bmz) Are Jointly Supporting The Covid-19-Relevant Medical And Pharmaceutical Products (Cmpp), The Antiretroviral (Arv) And Leather Regional Value-Chain (Rvc) Projects. These Rvcs Are Part Of The Joint Action Support Towards Industrialization And The Productive Sectors In The Sadc Region (Sips) Project. The Objective Of This Assignment Is To: 1.Facilitate A Regulatory Requirements Workshop For The Cmpp 2.Conduct In-Depth Assessments Of The Selected Cmpp Companies Current Product Certification Readiness Status, Relative To Relevant Regulatory/Qms Requirements And Identify Needs/Gaps 3.Develop Time-Bound Action-Plans To Address Identified Product Certification Readiness Gaps/Needs At The Companies Eligible Bidders Must Demonstrate The Following: 1.Average Annual Turnover Of Eur20,000.00 Over The Last 3 Financial Years 2.Average Of 3 Employees And Managers Over The Last 3 Calendar Years 3.At Least 2 Reference Projects On Medical Products Certification/Approval 4.At Least 2 Reference Projects On Quality Management Systems (E.G. Iso 13485) 5.Demonstrable Technical Experience In The Following Areas: Medical Products Certification/Approval; Regulatory Frameworks Particularly For Medical Devices; Quality Management Systems (Qms) E.G. Iso 13485; Product Master File Development 6.Sadc Regional Experience Tender Link :