Watershed Therapeutics is developing a novel drug-delivery system for recurrent urinary tract infections (rUTI) in women. The first-in-human study was originally planned for Colombia but pivoted to Panama (MINSA) and El Salvador (SRS) for faster regulatory timelines. bioaccess® adapted quickly to help navigate regulatory submissions in both countries, managing ethics committee filings, site feasibility, and coordination across multiple institutions.
Watershed Therapeutics needed to conduct a first-in-human study of their novel drug-delivery system for rUTI. Initial plans focused on Colombia, but the team pivoted to Panama and El Salvador for faster regulatory timelines — adding the complexity of coordinating drug study regulatory submissions across two countries simultaneously.
bioaccess® adapted the regulatory strategy, redirecting site selection to Panama and El Salvador. The team is now managing parallel submissions to MINSA and SRS while coordinating EDC build with Greenlight Guru, ethics committee filings across multiple institutions, and site feasibility in both countries.