Pearl Pathways, part of Versiti Clinical Trial Services

Pearl Pathways became part of Versiti Clinical Trial Services in 2023, bringing comprehensive regulatory, quality compliance, and clinical consulting expertise to the organization. The company serves emerging to mid-size biopharmaceutical, medical device, and diagnostic companies throughout the product development lifecycle.

The team provides regulatory strategy and global filing support, quality compliance services including GxP validation and auditing, and clinical services such as protocol development and data management. Their approach combines strategic guidance with project-based support, helping clients navigate FDA submissions, maintain regulatory readiness, and accelerate development timelines.

As part of the larger Versiti Clinical Trial Services platform, Pearl Pathways integrates with sister organizations including Cenetron, Quantigen, Pearl IRB, and Salus IRB, offering clients access to expanded capabilities across laboratory services, method development, and IRB review services.

Consider Pearl Pathways when your organization needs strategic regulatory guidance combined with hands-on quality compliance support for pharmaceutical, device, or diagnostic development. Their consultative approach and flexible team structure work particularly well for companies facing critical submission deadlines or regulatory challenges.

The integration with Versiti Clinical Trial Services provides added value when projects require complementary capabilities such as central laboratory services, IRB review, or specialized bioanalytical support, enabling more streamlined project coordination.

Pearl Pathways exclusively serves the life sciences and healthcare sectors, focusing on biopharmaceutical therapeutics, medical devices, and in vitro diagnostics. The team maintains deep expertise in FDA regulatory pathways including INDs, NDAs, and 510(k) submissions, as well as GxP compliance requirements specific to clinical research.

Their healthcare specialization extends to supporting diverse therapeutic areas through Versiti's broader platform, including oncology through Salus IRB's specialized review services and cellular therapy manufacturing support through donor pool management capabilities.

Emerging biopharmaceutical companies, medical device startups, and diagnostic developers in early to mid-stage development who need expert regulatory guidance and quality compliance support. Companies preparing first-in-human trials, seeking FDA breakthrough designation, or navigating complex global filing requirements benefit from their consultative expertise and flexible engagement approach.