We can assist in designing and implementing a quality system that meets regulatory expectations. We can support clients to prepare for upcoming internal audits and regulatory inspections to ensure their efficiency and success. We can also support clients in developing Corrective and Preventive Action Plans (CAPAs) derived from audit findings.
Quality System
• Assessment, design, and management (control) of quality system for regulatory affairs and pharmacovigilance.
• Generation, review, and streamlining of company policies, SOPs and Working Instructions/Guidelines.
• Establishment of performance metrics: identification and monitoring of key performance indicators to help measure a client’s system performance and effectiveness.
Compliance Monitoring & Quality Control
• Definition and oversight of compliance against internal processes, regulatory requirements, contractual agreements, and privacy and data protection laws.
• Assistance with ongoing monitoring of processes (internal and CRO/vendors) and deliverables (eg, ICSRs, PSURs, core labeling). Identification of process optimisation and quality improvement.
Audits
• Support of pharmacovigilance and regulatory audit programs.
• Pharmacovigilance system audits of the global function, regional and local offices, business partners, CROs, and third-party vendors.
• Definition, implementation, and supervision of CAPA’s.
Regulatory Authority Inspection Preparation
• Conduct of mock inspections and inspection readiness exercises.
• Design and delivery of training in preparation for inspections, including logistics and mock interviews.
• Advice on inspection coordination and management activities.
