New consulting service complements testing capabilities and provides clients with full range of regulatory compliance solutions

Linda Musitelli, Business Unit Manager, EBPT Consultancy Services, Eurofins Regulatory & Consultancy Services Italy, Linda.Musitelli@bpt.eurofinseu.com

At Eurofins BioPharma Services, we strive to provide our clients with comprehensive solutions that go beyond analytical testing. Eurofins BPT Consulting enhances our offering by providing expert consultancy services that complement our testing capabilities, enabling clients to meet regulatory compliance requirements, optimise processes, and ensure product safety and quality.

Regulatory and compliance challenges require an integrated approach. Companies operating in the biopharma sector must ensure that analytical results align with stringent regulatory requirements. Our consulting services bridge this gap by integrating world-class testing with regulatory strategy, facilitating compliance, and optimising operational efficiency through a comprehensive range of solutions, including:

• Regulatory Compliance and CMC Support: Expertise in dossier preparation, submission strategies, and post-approval compliance. This includes CMC documentation review to support drug development and lifecycle management (CTD, variations, regulatory intelligence).
• Facility and Equipment Qualification: Ensuring GMP compliance through structured validation plans and risk assessments (IQ, OQ, PQ protocols, regulatory compliance).
• Process Validation: Developing robust and reproducible manufacturing processes (E&L strategy, USP 1663-1665, BPOG, cleaning validation, disinfectant qualification).
• Safety and Toxicological Assessments: Assessing impurities, performing PDE calculations, and ensuring safety compliance (ICH Q3A/Q3B, Q3D, nitrosamines, ICH M7, OEL, QSAR, in-silico prediction).
• Environmental Risk Assessment: Identifying and mitigating environmental risks associated with manufacturing activities.

The increasing complexity of regulatory frameworks demands a structured approach to compliance. From early-stage product development to market authorisation and post-approval modifications, Eurofins BPT Consulting provides tailored expertise to navigate the evolving landscape. Eurofins BPT Consulting’s collaboration with Eurofins’ network of laboratories ensures that testing and consultancy efforts are aligned, reducing delays and improving regulatory submission outcomes.

By integrating analytical excellence with regulatory insight, we support streamlined compliance, minimise uncertainties, and help clients bring safe, high-quality products to market. Our combined approach offers:

• A single-source solution for testing and regulatory compliance.
• Faster and more efficient regulatory approvals.
• Enhanced product quality and safety assurance.
• Optimised operational efficiency and risk management.

Learn more about how Eurofins’ consultancy solutions can support your projects at Eurofins BPT Consultancy Services.