Current Job and Project Opportunities

Posting: Posting #: FDAAA Posting No. 2022-1

Job/Opportunity: DEADLINE January 28, 2022: South African Health Products Regulatory Authority (SAHPRA) seeks to hire a qualified U.S. firm to perform technical assistance to optimize its business practices, asses its regulatory practices, assess its stakeholder relationships, and develop a training program.

Organization: South African Health Products Regulatory Authority (SAHPRA)

The U.S. Trade and Development Agency (USTDA) has asked the FDAAA to publicize an RFP opportunity in South Africa with the South African Health Products Regulatory Authority (SAHPRA). USTDA has also posted this opportunity on Linked In, Twitter, and Facebook, but USTDA would like to reach our members specifically. There is a short fuse on this, as the RFP deadline is January 28!

SAHPRA has requested USTDA’s support to hire a qualified U.S. firm to perform technical assistance to (i) identify ways to optimize SAHPRA’s business processes, workflow, structures, and systems to support more efficient reviews of pharmaceutical and medical device (including In vitro diagnostics) applications utilizing reliance-based protocols, (ii) assess the current medical device framework and regulations in order to recommend improvements in processes to effectively regulate medical devices, (iii) assess SAHPRA’s relationships with key stakeholders to leverage resource sharing and inform risk-based decision making, and (iv) develop and implement the Training Program for SAHPRA personnel on reliance-based protocols.

Funding for this project is offered only on a fixed price basis (the U.S. firm selected will be paid in U.S. dollars from a $1,475,450 grant to SAHPRA from the USTDA).

The technical assistance summary and instructions on how to request a copy of the RFP can be viewed here: https://ustda.gov/business_opp_oversea/south-africa-sahpra-reliance-based-protocols-for-healthcare-products-technical-assistance/. Interested U.S. companies should ask all questions about this opportunity as directed in the RFP and should not ask SAHPRA questions about the RFP directly.