Specializing in Pharmacovigilance Quality Management Systems

---

Employees need to be trained on basic Pharmacovigilance as well as the relevant processes, procedures and documentation. We provide in-house training or web-based sessions on basic pharmacovigilance including updates on European regulations and Pharmacovigilance modules, your department’s procedural documents as well as address and your organizations individual training needs.  We are involved with development of training materials, facilitating the training and examining your departments understanding of the material through administration of assessments.

Procedural documents such as Standard Operating Procedures (SOPs) are the basis for any organization to be effective, efficient and compliant.  We can prepare SOPs and Working Practices to align with your processes or update your existing portfolio of procedures to assure they align with today’s global pharmacovigilance regulations.

It is critical to assure that your organization has a strategy to manage the safety profile of your respective licensing partner’s or co-marketer’s obligations or acquisition of a new product portfolio from another manufacturer. We can develop and implement your organization’s approach to insure compliance whether it is a single SDEA or a hub and spoke set of SDEAs for multiple partners.

A detailed quality management plan (QMP) includes planning, quality control, quality assurance and quality improvements. As a first step in assuring that your organization is aligned with this approach we perform a gap analysis of your system and identify areas of enhancement. As a result of this investigation a business process improvement map will be developed for the various gaps identified. Working closely with your team members, we rank business process improvements as they relate to implementation measures with the ultimate development of your organizations QMP which will meet FDA and EMA requirements.

To assure that your organization is meeting the regulatory obligations in an efficient manner, it is important to identify these and have an effective way to measure these indicators, such as  timeliness of ICSR reporting and PSUR submission, timeliness of variation implementations as well as adherence to safety commitments. Our organization provides guidance, approach and assessment of your performance indicators.

To assure compliance with the US and European Pharmacovigilance regulations and Good Pharmacovigilance Practice (GVP) guidelines, each organization need to be performing risk-based audits of their Pharmacovigilance system and its related quality system. Our cost-effective review can be fully tailored to your needs and requirements with deliverables of a mock EIR as well as a Corrective Action/Preventative Action Plan.