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Phase I, namely BA and BE in healthy volunteers ~1000 square meters clinical department comprising 60 beds in two independent units. Dosing sessions in large groups (up to 60 subjects in parallel). GCP/GLP compliant. 16,000+ volunteers database.
Whatever Phase 1 clinical pharmacology study you require, at Quotient Sciences you can expect rapid study startup and rapid recruitment through our locations in Jacksonville, Miami and Nottingham.
Claims substantiation plays a key role in a product’s success and helps ensure the product stands out against competitors. From moisturization and barrier function, to anti-aging and color changes, rely on RCTS for your product claims substantiation and efficacy testing needs.
Celerion is participating in the emerging area of biosimilar drug development by leveraging biologics regulatory expertise, proven large molecule and immunogenicity bioanalytical support, clinical study planning and execution and biopharmaceutics program development.
Celerion leverages more than 30 years of biologics drug development experience to enable early assessment viability of biosimilars, and bridge the gap between newly sourced products and patient studies.
Navitas' experience across innovator pharma and biologic Phase III studies, and pharmacokinetic studies enables us to partner with you to meet accelerated submission timelines while optimizing trial costs and regulatory risk of non-compliance.