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 matrices.
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
A4P solutions are built for each individual 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