Implementation and development: A4P can provide consultations, resource support and expert guidance for providers wishing to achieve and maintain regulatory compliance within bioanalytical aspects of GCP and GLP.
Management and oversight: A4P can provide expertise and resource to sponsors and providers to manage all aspects of the quality systems within drug development. We target solutions in the GCP/GLP areas, including:
- The production and development of quality manuals
- Policy documents
- Training records
- Supplier guidelines.
Our logistics team are experienced in supporting GDP, including provision of documents to support chain of custody and temperature records.
Audits and assessments: Through our network of independent experts or directly via A4P, we are able to provide support for audit and assessment of providers. We can provide corrective and improvement action plans where audit findings have revealed issues and shortfalls.
Regulatory compliance in bioanalysis: A4P can provide expertise and knowledge in attaining compliance towards global bioanalytical regulations and industry best practices.