PSC Biotech

Founded in 1996, PSC Biotech is a privately held, revenue-generating services firm specializing in regulatory compliance and quality assurance for the life sciences industry. It operates globally with a significant presence across North America, Europe, Asia, and the Middle East, positioning itself as a strategic partner for pharmaceutical, biotech, and medical device companies. The company's value proposition is built on deep regulatory expertise, a global delivery model with local insight, and a comprehensive suite of services designed to de-risk client operations and ensure market approval. While it operates in the Digital Health and AI/ML sectors broadly, its primary business model is providing high-value consulting and implementation services rather than developing proprietary therapeutics or software platforms.

Global network of regulatory and quality assurance experts providing consulting, validation, and compliance services. Service lines include Computer System Validation (CSV), Commissioning/Qualification/Validation (CQV), audits, metrology, and technical writing.

PSC Biotech competes with large Contract Research Organizations (CROs) offering consulting services, specialized regulatory/quality consulting firms, and the internal compliance departments of large pharmaceutical companies. Differentiation is achieved through its global local presence, team of former regulators, and broad, integrated service portfolio.