From Risk To Readiness: Strategic Regulatory Support
Eurofins PSS Insourcing Solutions provides biotech, pharmaceutical, and CDMO organizations with embedded regulatory expertise that strengthens compliance, accelerates timelines, and ensures audit readiness—without adding headcount. With over two decades of insourcing experience and a global footprint across 110+ client sites, PSS delivers strategic, on-site support tailored to each client’s regulatory landscape.
Our teams work hand-in-hand with our clients’ regulatory teams, offering critical support in regulatory strategy and submission preparation. PSS specialists routinely lead the development and finalization of CMC sections for global Clinical Trial Application (CTA) submissions, proactively reviewing molecule-specific strategies and providing informed technical guidance to support decision-making that impacts product approvals across geographies. We help clients navigate regulatory changes by evaluating the impact of deviations and proposed modifications, providing timely and clear guidance that enables well-informed decision-making to maintain compliance.
Technical writing is another core strength of our regulatory support. PSS professionals draft and refine technical documents, transforming raw data into clear, structured content that meets submission standards. We collaborate closely with scientists and client leadership teams to ensure accuracy, consistency, and clarity, and we support peer-reviewed publication efforts when needed.
Our impact is best illustrated through real-world success. At a global CDMO, PSS was engaged to address a backlog of over 600 Corrective and Preventative Action (CAPA) deviations following an FDA 483 letter. Our team of six quickly became a stabilizing force, implementing group meetings, supporting the client’s new investigator qualification program, and reducing deviation closure time by 26% within the first year. All 600 CAPAs were successfully addressed. Despite high turnover among client FTEs, the PSS team remained a consistent and high-performing presence.
In another client engagement, PSS supported the setup and validation of a new GMP facility under a tight six-month timeline. Our team coordinated with contractors, performed EMPQ testing, including environmental monitoring, disinfectant efficacy, and facility validation, to meet USP, JP, and Ph. Eur. standards, and identified critical system issues that were resolved before launch. The facility was validated on time, and the client retained the PSS team for ongoing support—now expanded to hundreds of employees globally.
Eurofins PSS is more than a managed service provider—we are a strategic partner in insourcing excellence. Our behavioral-based hiring, operational rigor, and access to Eurofins’ global network ensure that our clients receive dependable, compliant, and future-ready support. Whether managing CAPAs, preparing submissions, or validating facilities, PSS delivers results that build trust and long-term value.