A4P Consulting Ltd

A4P Consulting Ltd

A4P Consulting Ltd

A4P provides value added, cost effective, scientifically robust and regulatory compliant solutions in: The application, selection, interpretation and bioanalysis of biomarkers and pharmacokinetics. Provision of logistic services for time and condition critical consignments. Quality systems consultation and implementation. Oversight and evaluation of outsourced providers. Founded in 2011 and located in the UK at Discovery Park, Sandwich, A4P have considerable drug development experience and knowledge acquired within Pharmaceutical, Biotechnology and CRO organisations. A4P approaches range from expert consultations, to focused problem solving assignments through to fully embedded resource. A4P solutions Application, selection, interpretation and bioanalysis of biomarkers and pharmacokinetics In biomarkers, A4P provide expertise in the selection, use and interpretation of clinical biomarkers across numerous therapeutic areas. In bioanalysis for biomarkers and pharmacokinetics, A4P delivers data through engagement and management of CRO suppliers for Pre-clinical and Clinical studies in many therapeutic areas and biological matrices. A4P has expertise in small and large molecules analysis using Chromatographic, Mass Spectrometry and Ligand Binding assay platforms. A4P experience covers method sourcing, troubleshooting and re-development, assay transfers, translation of assays from pre-clinical to clinical, assay validation, study sample analysis and reviews of validation and sample analysis data and reports, assay summaries and regulatory submissions. Logistics A4P has sector leading expertise and proven achievements in global shipping of time and condition critical materials. A4P’s client customised, fully managed and competitively costed solutions involve extensive research into vendor selection, focused detailed planning and rigorous oversight of every step in the logistics chain. A4P provides delivery solutions of cell therapy materials, active pharmaceutical ingredients, biological products and trial specimens, materials covered by dangerous goods regulations, bulk specialist equipment and small parcel materials and documents. A4P’s expertise and experience in logistics extends into operational support for clinical trial management of biosamples. This includes protocol set up and production of lab manuals, related aspects of safety assessments and patient screening and stratification, shipments and laboratory liaison. Quality Systems Consultation and Implementation A4P’s quality system solutions delivers expertise and resource in the implementation, management and oversight of provider quality systems relevant to drug development. The solutions are particularly directed towards laboratory GCLP/GLP and logistic provider GDP compliance. A4P provides the necessary knowledge for the development of quality manuals, training records and laboratory and provider guidelines together with corrective action plans resultant from audit findings. Evaluation and oversight of outsource providers A4P provide detailed scientific, technology and business appraisals for the sourcing, evaluation and contracting of appropriate providers selected to meet clients’ specific needs and requirements. In both bioanalysis and logistics, outsourcing to expert providers is an effective means of flexibly solving resource and expertise issues. However, in drug development, regulators require that the sponsor is responsible for demonstrating oversight irrespective of provider accountability. A4P provides resource and expertise in supplier oversight through quality documented procedures and processes, readily adaptable to individual clients needs whilst ensuring compliance with the latest regulatory requirements and industry best practices is met.

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