PV Focus: Specialist in Pharmacovigilance Auditing
PV Focus is a small specialty company established in December 2004 that has successfully centered its business on the provision of Pharmacovigilance Audits and related services to the Pharmaceutical Industry.
Pharmacovigilance Auditing Services
As a result of the increased focus on Drug Safety, internal Audits of Pharmacovigilance Systems have become a requirement for all Marketing Authorisation Holders (MAHs). This requirement is clearly specified in European Guidelines (Eudralex Volume 9A) and companies are often cited in Pharmacovigilance Inspections due to insufficient Pharmacovigilance Auditing arrangements.
Pharmacovigilance Inspection Support Services
Due to its experience of both Audits and Regulatory Inspections at a global level, PV Focus is a partner of choice to assist with the performance of Pharmacovigilance System Audits and can also support the preparation of Regulatory Inspections.
PV Focus is also providing a service of regulatory review specifically for Pharmacovigilance and Clinical Drug Safety: Safety Observer is a newsletter that covers all regulatory requirements applicable to the management of Pharmacovigilance and Clinical Drug Safety Systems.