PVpharm
The Reliable Pharmacovigilance and Clinical Safety Experts

As the pharmaceutical industry expands in size and global reach, regulators are becoming more concerned about drug safety and quality. This has led to frequent changes in the regulatory landscape. However, complying with the complex pharmacovigilance, clinical safety, regulatory, and quality requirements is a task easier said than done. The situation necessitates organizations to find the right partner that can help them navigate the complex terrain.

Enter PVpharm.

“Our team of professionals understands the legislative frameworks within the pharmaceutical space. They work with marketing authorisation holders, sponsors of clinical trials, and other life science service providers to offer pharmacovigilance, clinical safety, regulatory, and quality solutions,” says Jose Alberto Ayala Ortiz, CEO, PVpharm.

PVpharm offers an EU-Qualified Person for Pharmacovigilance (QPPV) and local PV contact persons in all EU countries, according to the EU Directive 2001/83/EC. For clients who wish to register medicinal products with the European Medical Agency (EMA), PVpharm delivers Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) consultancy and data management services to assist them in preparing for Identification of Medicinal Products (IDMP) implementation.

As an all-around pharmacovigilance expert, PVpharm specializes in supporting clients with case management, signal detection, preparation, and submission of periodic reports.It also provides specialized pharmacovigilance training services. Those who require assistance with medical writing for pharmacovigilance can bank on the company’s prowess to deliver top-quality documents, including Pharmacovigilance System Master File (PSMFs), Risk Management Plans (RMPs), periodic safety update reports (PSURs), and development safety update reports (DSURs) according to the EU Good Pharmacovigilance Practices guidelines.

Another area of expertise for PVpharm is risk-based pharmacovigilance audits that align with the EU guidelines of GVP Module IV. PVpharm assists clients with GCP and GMP audits while implementing and managing their quality assurance system to improve risk management and governance processes.

Clients reach out to PVpharm for strategic pharmacovigilance consultancy as well. The company collaborates with the clients’ teams to assist in their pharmacovigilance activities, including collecting and managing safety data, evaluating and detecting safety issues, and proactive risk management.

The company always strives to understand their needs by indulging in communication. This enables PVpharm to define the agreements and the services beforehand. The communication continues at every stage of the project to keep clients aware of the key milestones and achievements.

The comprehensive service offering has enabled PVpharm to collaborate with several large pharma companies with complex pharmacovigilance systems. For example, it collaborated with a Top 10 U.S.-based company to deliver strategic levels of support for their pharmacovigilance system.

The client was struggling to manage the high volume of information on an everyday basis across all their global locations. PVpharm enabled them to address this challenge and produce the reports. For another client, a U.S.- based biotechnology company, PVpharm improved the entire pharmacovigilance system in line with EU requirements.

PVpharm constantly upholds its core value of delivering pharmacovigilance services with a perfect understanding of the regulatory frameworks. The company seeks to strengthen its client relationships by fostering better communication. PVpharm has also increased the number of strategic alliances to work on various projects.