13 Nov Paracelsis
Paracelsis is a contract research company offering a comprehensive range of laboratory-based and consultancy services to fulfil the preclinical (nonclinical) development needs of its customers. Our experience is primarily in the pharma/biotech sector with active pharmaceutical ingredients (‘APIs’ – including conventional drugs, peptides/proteins and vaccine antigens), metabolites, excipients, formulation impurities, and extractables/leachables. We have extensive in vivo experience with a variety of parenteral and non-parenteral dose forms/delivery systems but of particular note is our expertise in nasal drug delivery.
The company founder and director, a PIL and PPL Holder under the Animals (Scientific Procedures) Act 1986, is a Fellow of the Society of Biology (FSB) and European Registered Toxicologist (ERT) with a proven track record, spanning over 25 years, supporting products from concept through to MAA/NDA approvals.
Paracelsis works closely with its customers to identify their preclinical development needs and provide the necessary and timely support to meet strategic milestones and timelines. Services routinely undertaken include in vivo pharmacokinetic and tolerability studies, pharmacokinetic data analysis using PhoenixÂ® WinNonlinÂ®, monitoring of outsourced GLP toxicology studies, safety (toxicology) assessments, and production of expert scientific documents to support regulatory submissions (CTA/IND, MAA/NDA etc.).