*Please note: Any laboratory-based in vivo experimental work carried out by Paracelsis is subject to having the appropriate UK Government (Home Office) licensing authority under the Animals (Scientific Procedures) Act 1986 as well as local Ethical Approval

Services

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. 


A snapshot of services that we routinely provide is shown below.  However, the list is not exhaustive and we would be happy to discuss your individual requirements with you.

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

Laboratory-based (in-house) studies*


  • In vivo pharmacokinetic and tolerability studies


  • In vivo non-invasive imaging studies (e.g. gamma scintigraphy, magnetic resonance imaging (MRI))


  • 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)