United States
Eurofins Regulatory and Consultancy Services supports pharmaceutical companies in identifying the most effective regulatory pathway to ensure product safety and quality. We work closely with your teams to navigate regulatory challenges through a science‑ and risk‑based approach that provides clear, actionable solutions. Thanks to our experience across diverse manufacturing and regulatory environments — from small molecules to biologics and ATMPs — we translate your needs into robust, tailored strategies that drive successful outcomes.
E&L and qalification
Regulatory strategy
The draft guideline introduces harmonised expectations for E&L risk assessment.
BPC supports ethanol approval for hygiene and disinfectant applications.
EMA expectations are increasing for ERA documentation in submissions.
New guidance strengthens requirements for polymeric materials and single-use systems.
EMA and FDA continue tightening nitrosamine risk assessment requirements.
Authorities strengthen monitoring of PFAS in materials and packaging systems.
New EU initiatives aim to accelerate development of advanced therapies.