We are highly experienced with: i) conventional drugs, peptide and protein drugs, and vaccine antigens; ii) a variety of small and large animal models and; iii) a range of parenteral and non-parenteral (transmucosal) administration routes.
We have extensive experience developing nasal drug products and intranasal drug delivery systems using conventional as well as novel excipients such mucoadhesive chitosan- and in-situ gelling pectin-based systems.
As an extension to preclinical development activities, we have also been involved with pharmacokinetic analysis of clinical (human) datasets. We use industry standard Phoenix WinNonlin software (Pharsight/Cetara) for all of our routine pharmacokinetic and toxicokinetic analyses.
We are a contract research organisation (CRO) founded in 2012; the companies mission is to provide its customers with a comprehensive 'one-stop' solution with respect to their preclinical/nonclinical development needs.
The Founder, a Fellow of the Society of Biology (FSB) and a UK/EUROTOX Registered Toxicologist (ERT), has extensive (>25 years) preclinical experience.
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.
Our experience is primarily in the pharma/biotech sector with drugs and their metabolites, novel excipients, formulation impurities including degradation products, and extractables and leachables.