Pharmacokinetic bioanalysis

Managing outsourced PK bioanalysis through expertise, problem solving and resource

In managing the generation of biofluid concentration data for PK studies, A4P deliver:

  • Sourcing, evaluation, selection and contracting of CRO providers from across the globe
  • Comprehensive oversight and delivery of bioanalysis studies; from sample to submission
  • Supply of scientifically robust data; on time, in budget, in compliance
  • Reviews of bioanalytical reports, project and product assay summaries and regulatory submissions

Our bioanalytical experience and expertise encompasses

Small and large molecules using Chromatographic, Mass spectrometry and Ligand Binding assay platforms

Pre-clinical and Clinical (GLP and GCLP) studies across a whole range of therapeutic areas and biological matricies

All aspects of assay development: method sourcing, troubleshooting and redevelopment, assay transfers across and between providers and translation of assays from the pre-clinical to clinical

Assay validation and fit for purpose considerations

Study sample analysis

A4P solutions are built for each indivdual client's requirements.

  • Output is supported by quality documented procedures and processes
  • All are readily adaptable to individual clients needs whilst ensuring compliance with the latest regulatory requirements and industry best practices