Applicable Audits

The market for Human Health Products is truly global and wherever a drug is distributed, there is a need to collect safety information and most countries require to submit safety information to Regulatory Authorities.

The responsibilities for an effective Global Pharmacovigilance System may be distributed around the world and any organization taking part in the processes involved should be considered for an audit.

This includes:

• Central groups involved with Global Pharmacovigilance Processes (Corporate level)
• Local affiliates (i.e. specific country organization)
• Partners:
  • Licence Partners
  • Distributors
• Contractors
• Contract Research Organizations
• Contract Safety Surveillance Organizations

This may be more than Corporate Audit Teams can handle due to their potential lack of capacity or experience in this area. Still, Regulatory Authorities Inspectors expect that all such units are considered in the planning for Pharmacovigilance Audits, depending on the level of risk associated with each stakeholder.

PV Focus provides Expert Pharmacovigilance Auditing to assist with this growing business need.

>> More about our Pharmacovigilance Auditing

PV Focus can also assist you in establishing or improving your Pharmacovigilance Audit Strategy.

>> More about our Consulting Services

Although PV Focus expertise lies predominantly in the area of Prescription Pharmaceuticals, this expertise can be transferred to other areas where similar requirements are in place or will be implemented in the near future, including:

• OTC Pharmaceuticals
• Medical Devices
• Animal Medicinal Products
• Food Supplements