20Aug

Case Study: Meeting Commercial Readiness Deadlines with Multi-Skilled QA and Validation Experts

August 20, 2025by assureallcin Staffing

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

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06Aug

Strategic Staffing in Action: Supporting EU Regulatory Readiness with a Contract CMC Lead

August 6, 2025by assureallcin Quality Compliance, Staffing

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:

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