A non-clinical CRO, Galileo Research provides strong support to those involved in the early stages of drug discovery, as well as the development of drugs, medical devices, cosmetics and food supplements. The organisation brings a nuanced scientific perspective to research and development (R&D), acquired over three decades of experience in the pharmaceutical sector. This business acumen paves the way for an in-depth understanding of regulatory affairs, empowering it to expedite the registration process and market of launch of therapeutic products.
The organisation’s commitment to crafting detailed R&D protocols is paralleled by its dedication to fostering open lines of communication with its clients. Stakeholders are consistently updated on the research’s progress and outcomes, affirming the firm’s stance on transparency. Through these continuous interactions, Galileo Research promptly reports deviations in non-clinical studies, offering relevant solutions to efficiently manage them. Such practices have solidified the Italian CRO’s reputation as the preferred R&D partner in the Italian pharmaceutical industry.
Our continuous information exchange has resulted in clients likening us as their dedicated research laboratory, creating the impression that we operate as part of their company
The firm’s strength lies in its international network— which includes clinical CROs and analytical laboratories known for their expertise in specimen analysis using cutting-edge instruments like mass spectrometry and NMR. This collaborative network enables Galileo Research to provide comprehensive R&D solutions.
Galileo Research taps into this wealth of expertise and technological resources to support numerous clients in streamlining drug discovery, development and product launch. For instance, the Italian CRO leveraged its extensive resources and instruments to design in-vivo and in-vitro models that simulated a target disease to study response to treatment. The strategic approach allowed the client to effectively demonstrate the drug’s efficacy, ultimately securing approval from the necessary regulatory bodies.
Besides tackling scientific hurdles, Galileo Research navigates regulatory complexities to achieve successful market registration. A notable instance involved a client seeking to expedite the regulatory approval for a food supplement’s registration and market launch. The firm responded by designing strategies for GLP-compliant non-clinical studies that adhere to international guidelines.
The CRO’s comprehensive understanding of regulatory affairs enables it to consistently develop strategies that gain relevant authorities’ approval. However, its proficiency in the field gained greater significance after the revision of medical device regulations (MDR) in 2017. The modification spurred waves in the field of medical device R&D, necessitating companies to review and update their existing products to meet the new regulatory requirements. Galileo Research also played a major role in helping companies align their R&D activities with the amended MDR requirements, ensuring compliance for the seamless market launch of new products.
These initiatives demonstrate Galileo Research’s commitment to client support, leveraging the expertise of its senior laboratory staff and the fresh perspectives of its junior researchers. Offering these advantages to clients, Galileo Research continues to expedite its research goals to facilitate the discovery, development, regulatory approval and market launch of new therapeutic products.
