Empower Pharmaceutical Company Compliance through Expert Pharmacovigilance

A deep Dive into our QV Hub 

PQE Group can act for its clients both as Marketing Authorization Holder (MAH) and/or as service provider. In line with this new assumption, PQE Group has implemented a Pharmacovigilance Quality Management System (PV QMS) which covers all the pharmacovigilance tasks and activities and related quality assurance activities. Within these activities we can identify and work with:   

• Adverse Event Reporting: PQE Group excels in streamlining adverse event reporting processes. By implementing advanced technologies and robust reporting systems, the company ensures that adverse events are promptly identified, documented, and reported in compliance with global regulatory requirements. PQE Group provides a fully managed and well-maintained pharmacovigilance safety database solution. Our database is a cloud-based, user-friendly, easy-to-use, regulatory-compliant, and end-to-end pharmacovigilance/drug safety database software.  
  
  
• Literature Monitoring: Unswerving global or local literature monitoring services support signal management and inform the benefit-risk profile of your medicine. Our multidisciplinary literature surveillance team performs end-to-end local and global literature safety surveillance activities, using global biomedical databases and monitoring social media.  
  
  
• Safety and Medical Writing: PQE Group provides proven pharmacovigilance aggregate reporting services, which are considered a large responsibility and take substantial effort. Based on the marketing authorization status, the MAH must prepare different types of reports, including pre-approval aggregate reports, which are primarily Development Safety Update Reports (DSURs) and post-marketing aggregate reports, Periodic Safety Update Reports (PSURs), and Periodic Adverse Drug Experience Reports (PADERs). 
  
  
• Signal Detection and Analysis: Starting from 01st January 2025 all MAHs will have to integrate the data into their own signal management processes with those from the EudraVigilance data analysis system (EVDAS). Leveraging sophisticated data analytics tools (including EVDAS), PQE Group supports pharmaceutical companies involved in the pilot phase to put in place an effective and efficient process to ensure that signals are detected and managed in compliance with the regulatory EVDAS requirements.  
  
  
• Risk Management Strategies: Recognizing the dynamic nature of the pharmaceutical industry, PQE Group collaborates with clients to develop and implement robust risk management strategies. These strategies are designed to optimize benefit-risk profiles and enhance patient safety throughout a product's lifecycle. 
  
  
• Regulatory Compliance: Staying abreast of the ever-evolving regulatory landscape is a hallmark of PQE Group. The company provides expert guidance to clients, ensuring compliance with international pharmacovigilance regulations and guidelines. 
  
  
• QPPV/LPPV and Pharmacovigilance System Master File (PSMF): PQE Group’s team of EU/UK Qualified Persons for Pharmacovigilance (QPPV) and their deputies, as well as local contact persons responsible for PV (LCPPV), can help to set up and maintain complex global PV systems. Our team has extensive experience in Pharmacovigilance System Master File (PSMF) drafting processes, starting from the summary of the PV system and/or maintenance of Article 57 database (XEVMPD).  
  
  
• Regulatory Intelligence in Pharmacovigilance: PQE Group offers comprehensive pharmacovigilance consulting services that can help every life sciences organization create internal regulatory intelligence pharmacovigilance processes, thereby complying with the Health Authorities’ policies and laws. Through the use of artificial intelligence, it is possible to offer an intensive monitoring service of all regulatory sites, guaranteeing a high standard of compliance with the required regulatory requirements. 
  
  
• Develop Standard Operating Procedures (SOPs): Establish clear and comprehensive SOPs for all pharmacovigilance processes, including Pharmacovigilance Quality Assurance processes. 
  

Technological Innovations 

PQE Group is at the forefront of integrating cutting-edge technologies into its pharmacovigilance services. Artificial intelligence, machine learning, and data analytics are employed to sift through vast amounts of data efficiently, identify patterns, and detect potential safety signals with a level of precision that was once unimaginable. The implementation of pharmacovigilance database enhances the company's capabilities in managing and analyzing safety data. This database facilitates seamless collaboration between pharmaceutical companies and regulatory authorities. By implementing sustainable practices, PQE Group create a positive working environment. Going paperless is one way for PQE Group to begin sustainable marketing. It demonstrates our commitment to conserving natural resources, reducing the carbon footprint and contributing to a more sustainable future. 

Future Outlook 

As the pharmaceutical industry continues to evolve, PQE Group remains committed to staying ahead of the curve. The company has a strong global presence and is continuously improving its technological capabilities to provide even more comprehensive pharmacovigilance services to meet the evolving needs of its customers. 

In the realm of pharmacovigilance, PQE Group stands out as a beacon of excellence, combining seasoned expertise with cutting-edge technology. Through its unwavering commitment to safety, regulatory compliance, and innovative solutions, the consultancy has become an indispensable partner for pharmaceutical companies seeking to navigate the complex landscape of drug development while ensuring the highest standards of patient safety.