Background A mid-sized U.S.-based medical device manufacturer was preparing to initiate a clinical trial for a new Class II device. The company needed additional Clinical Research Associate (CRA) support to oversee trial sites, ensure protocol compliance, and meet regulatory expectations. With limited internal bandwidth and a fast-approaching study start date, the client turned to Assurea’s
Client: Mid-sized biotech company developing novel biologics.Industry: Biotechnology / Life SciencesPositions: 2 QA Specialists and 3 Validation Engineers Background A biotech company was advancing a promising therapeutic candidate through clinical studies toward commercialization. To meet FDA submission timelines, validation of their GMP manufacturing and QC lab equipment and systems had to be completed within six
As part of preparing for commercial readiness, a Phase 3 biotech client faced a pivotal challenge: expanding into the European Union while meeting critical regulatory filing and inspection requirements. Their internal regulatory team was well-versed in U.S. requirements but lacked specific expertise in EU Module 3 expectations, centralized procedures, and regional submission strategy. The challenge: