Expert bioanalytical solutions for your drug development program

In managing the generation of bioanalytical data for pre-clinical and clinical studies, A4P can support the following activities:

• Sourcing, evaluation, selection and contracting of CRO providers from across the globe.
• Comprehensive scientific oversight and project management of outsourced bioanalytical activities.
• Reviews of bioanalytical documents, reports and product assay summaries.

Our bioanalytical expertise encompasses;

• PK, ADA and Biomarkers for small and large molecule therapeutics utilising the following methods;
• Chromatographic and Mass spectrometry
• Ligand Binding assay platforms
• Immunohistochemistry
• Flow Cytometry
• Genomics
• Pre-clinical and Clinical (GLP and GCP) studies across a range of therapeutic areas and biological matrices.
• All aspects of assay development: method sourcing, troubleshooting, redevelopment, assay transfers and translation of assays from pre-clinical to clinical.
• Assay validation and fit for purpose considerations in line with current regulatory guidance and best practice.
• Review of documentation in support of sample analysis studies.