Products and Services
PV Focus brings valuable experience of both Audits and Regulatory Inspections at a global level (FDA, MHRA and other agencies). PV Focus has developed its own approach to Auditing Pharmacovigilance Systems to cover all relevant regulatory requirements and regulations for Pharmacovigilance and Clinical Drug Safety processes. PV Focus can also support the preparation of Regulatory Inspections through Training and Mock inspections.
The experience of PV Focus in Auditing Pharmacovigilance and Clinical Safety makes us a partner of choice for our clients. We guarantee a structured and thorough review of applicable arrangements, and we have a proven track record of providing quality deliverables in compliance with agreed timelines.
PV Focus is also providing a service of regulatory review specifically for Pharmacovigilance and Clinical Safety: “Safety Observer” is a newsletter distributed on a monthly basis to cover all regulatory requirements applicable to the management of Pharmacovigilance and Clinical Drug Safety Systems. This service was launched in March 2005 in partnership with SUNNIKAN Consulting. It is now used by several hundred Pharmacovigilance professionals world-wide to monitor the constantly changing regulatory requirements.