Paracelsis Ltd

Paracelsis is a preclinical/nonclinical contract research organisation (CRO); the companies mission is to provide its customers (pharma and biotech companies, academic institutions etc.) with a comprehensive 'one-stop' solution with respect to their preclinical/nonclinical development needs. We have a proven track record spanning the lifecycle of preclinical development ranging from the conduct of proof-of-concept pharmacokinetic and tolerability studies through to GLP toxicology studies and drafting of scientific documents to support pharma/biotech products through various stages of clinical development and ultimately to market approvals in Europe, USA and Australia. Of particular note is our extensive experience of evaluating nasal drug products and intranasal drug delivery systems. Paracelsis offers an eclectic mix of laboratory-based and consultancy services in the preclinical setting which can be tailored and aligned according to customer needs, stage of product development, etc. Laboratory-based (in-house) studies •In vivo pharmacokinetic and tolerability studies •In vivo non-invasive imaging studies (e.g. gamma scintigraphy, magnetic resonance imaging) •Pharmacokinetic data analysis using Phoenix WinNonlin (clinical and preclinical datasets) Laboratory-based (outsourced) studies •GLP toxicology studies (including CRO selection, protocol generation, study monitoring and reporting) •In silico (computer-based) predictive toxicology (e.g. using Lhasa’s Derek Nexus and Leadscope software) Consultancy •Safety (toxicological) assessments on drugs, metabolites, excipients, impurities, extractables and leachables etc. •Expert interpretations •Scientific reports and documents to support regulatory and ethical submissions (CTA/IND, MAA/NDA etc.) •Representation at meetings with regulatory agencies •Assessment of preclinical development needs and generation of preclinical development plans •Project management