As experts in biomarkers, bioanalysis, pharmacokinetics, logistics and quality systems management A4P deliver scientifically robust, regulatory compliant, cost effective and value-added solutions for the global life sciences sector.
Biomarkers and pharmacokinetics.
A4P delivers expertise in the selection, use, interpretation and bioanalysis of clinical biomarkers and pharmacokinetics across multiple therapeutic areas by engagement and management of CRO suppliers for Pre-clinical and Clinical studies
A4PBio has expertise in small and large molecules analysis using Chromatographic, Mass Spectrometry, Ligand Binding, Immunohistochemistry and nucleic acid technology assay platforms, across all aspects of bioanalytical study support.
Logistic services for time and condition critical material shipments.
A4P client customized, fully managed and competitively costed solutions in logistics covering cell therapy materials, active pharmaceutical ingredients, biological products and clinical trial specimens, materials covered by dangerous goods regulations, bulk specialist equipment and small parcel materials and documents.
A4P has sector leading expertise and proven achievements in global shipping. We undertake extensive research into vendor selection, provide focused detailed planning solutions and rigorous oversight of every step in the logistics chain.
A4P expertise and experience in logistics extends into operational support for clinical trial management of bio-samples. 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 quality system solutions delivers expertise and resource in the implementation, management and oversight of providers, particularly in GCLP/GLP and logistic provider GDP compliance.
A4P supports this through the development of quality manuals, training records and laboratory and provider guidelines together with corrective action plans resultant from audit findings.
Oversight and evaluation of outsourced 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.
For bioanalyticals’ and logistics activities, outsourcing to expert providers is an effective means of flexibly solving resource and expertise constraints. However, in drug development, regulators require that the sponsor is responsible for demonstrating oversight irrespective of provider accountability.
A4P provide 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.
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 services range from expert consultations, to focused problem solving assignments through to providing fully embedded resource.