Improve Patient Care and Safety
We strive towards an efficient and effective quality management system within the pharmaceutical industry to ensure that activities relating to pharmacovigilance (PV) are handled in compliance with applicable regulatory requirements and company expectations.
Our focus is to ensure compliance with the regulatory requirements without creating a burden to the daily operational activities.
Pharmacovigilance Quality and Auditing
We offer a wide range of services in various aspects of pharmacovigilance and quality.
Tailored audits, training or support – specific to your needs.
Global Auditing
We perform any type of audit in all aspects of pharmacovigilance and GCP safety based on the regulatory requirements in the EU (EMA), US (FDA), Japan (PMDA) or other local requirements – either onsite or remotely
Inspection Readiness and Support
From preparation until the closure of an inspection, we can provide support include a CAPA assessment. Additionally, a mock-inspection can be performed as well to get the team ready for the inspection with tips and tricks along the way.
Training
Whether it is a training to get a better understanding of the pharmacovigilance regulatory requirements or a training to get acquainted with the quality mindset, we can create and provide trainings specific to your needs.
Process optimization and gap analysis
Each quality system consists of its own structure and processes which should be evaluated on a continuous basis. We provide services to evaluate and improve the quality management system, process optimization or provide a gap analysis of the quality system.
Compliance
The performance of PV activities need to be assessed continuously to ensure quality, timely submissions, oversight etc. We can provide support in compliance management such as PV system implementation, safety compliance monitoring or vendor oversight.
Standard Operating Procedures
Procedures are one of the key documents to ensure adherence and consistent performance of PV activities. We can support but also write completely new procedures, update existing procedures or provide feedback based on the review of existing procedures.
Cheung Pharma Consultancy 