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Company Description
PI Health Sciences Ltd is a science-driven partner to the global pharma and biotech ecosystem, providing an integrated continuum of discovery, development, and manufacturing solutions that move programs from concept to clinic and into commercial supply. Its discovery offering spans integrated drug discovery for small molecules and biologics, uniting synthetic and medicinal chemistry, discovery biology, and advanced AI and computational chemistry to accelerate target validation, assay development, screening, ADME/DMPK, and in vivo efficacy, while pre-clinical and toxicology capabilities support dose projection, biomarker analysis, GLP study design, protocol oversight, data evaluation, and regulatory-ready reporting. Development services focus on process R&D from early phase through commercialization, covering process optimization and validation, phase-appropriate scale-up under GMP and non-GMP, high-potency handling, and rigorous regulatory alignment, complemented by analytical R&D for method development and validation, genotoxic impurity analysis, stability and forced degradation, trace metals, and potent compound analytics, as well as comprehensive process safety evaluations and dedicated project management that leverages agile methods, cloud collaboration, and advanced data analytics. Enabling technologies include a Center of Excellence for flow chemistry supporting R&D through pilot-scale continuous manufacturing and GMP/non-GMP production, and integrated biocatalysis pathways that reduce waste, energy consumption, and cost while efficiently resolving chiral intermediates. Manufacturing solutions cover preclinical, clinical (phases 13), and commercial supply of APIs and HPAPIs with certified facilities in India and Italy; capabilities include advanced reactors, precise process control, chromatographic purification, handling of OEB4 potency levels, and specialized expertise in deacylated phospholipids and cytostatic nucleosides. With co-located, cross-functional teams, flexible engagement models, transparent data-driven communication, and a partner-first culture, PI Health Sciences delivers speed, reliability, and quality from IND-enabling studies through lifecycle management, supported by a global footprint that spans sales, headquarters, R&D, manufacturing, and supply chain offices, and a sustainability ethos framed as reimagining a healthier planet.
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