CDMO

Firalis Molecular Precision (FMP) is a specialized Contract Development and Manufacturing Organization (CDMO) dedicated to supporting biotech and diagnostic companies in transforming early-stage scientific discoveries into robust, validated, and commercially viable diagnostic products. Acting as a bridge between research and market readiness, FMP provides fully integrated expertise across the entire development lifecycle of molecular diagnostics.

Our team has deep experience in assay development for RUO, LDT, and IVDR/IVD applications. We support biomarker translation, whether based on proteins, nucleic acids, or genetic markers, and design assays such as ELISA, qPCR/dPCR, immunoassays, or multiplex panels. This scientific foundation is reinforced by strong operational capabilities enabling the development of high-performance, scalable diagnostic solutions.

Firalis Molecular Precision also offers comprehensive pilot batch production and early manufacturing services. We internalize critical supply-chain components to secure long-term reagent availability, optimize production processes, and ensure that each assay is industrially viable. These activities are conducted under quality systems aligned with ISO 13485, ensuring rigorous control, traceability, and consistency.

A core strength of FMP lies in analytical and clinical validation. We perform full analytical validation following FDA, IVDR, and CLSI guidelines, and design and support clinical performance studies with robust statistical methodology. Our team also conducts extensive stability studies, aging assessments, and environmental stress testing to guarantee that developed products meet regulatory and market expectations.

From a regulatory standpoint, Firalis Molecular Precision provides end-to-end support for FDA submissions—including RUO, LDT, 510(k), and De Novo pathways—as well as IVDR technical documentation and interactions with Notified Bodies. We assist clients in navigating risk management, design control, and the preparation of all documentation required for compliance.

Through integrated project management, technical know-how, and regulatory expertise, FMP empowers startups, small companies, and innovative research teams to accelerate the transition from concept to market. Our mission is to provide the scientific rigor, operational excellence, and regulatory support needed to transform R&D innovation into reliable, validated, and commercially successful diagnostic products.