Quality systems Implementation and management through consultancy, expertise and resource solutions
A4P delivers solutions in the implementation, development, management and oversight of the quality systems and regulatory compliance required by providers and sponsors in drug development.
Implementation and development: A4P provides consultations, resource support and expert guidance for providers wishing to achieve and maintain compliance towards GCLP and bioanalytical aspects of GLP.
Management and oversight: A4P provides expertise and resources to sponsors and providers to manage aspects of the quality systems in drug development. We target solutions in the GCLP/GLP and GDP areas. A4P provides resource for the production and development of quality manuals, SOP’s and policy documents, training records and supplier guidelines.
Audits and assessments: Through our network of independent experts or directly by A4P, resource and expertise is provided to audit and assess providers in their GxP status. We provide corrective and improvement action plans where audit findings have revealed issues and shortfalls.
Regulatory compliance in Bioanalysis: A4P provides expertise and knowledge in supporting interpretation and process improvements in compliance towards global bioanalytical regulations.