Expert pharmacovigilance assistance streamlines the regulatory inspection process

In today’s life sciences industry, many pharma and biotech companies hire outside vendors to help meet business needs, and this assistance is especially critical during regulatory inspections. Quality and communication are key to ensuring outsourced work passes muster; otherwise, the company may end up spending extra time managing its vendors, which could eventually leave less time for the strategic work that moves the pipeline forward.

At Med Communications, quality and communication are at the heart of everything we do, and our clients take notice. After a recent EMA inspection with our Pharmacovigilance department, one of our biopharmaceutical clients shared this testimonial.

From the outset, Med Communications delivered a comprehensive strategy tailored to our organizational needs, ensuring compliance with Good Pharmacovigilance Practices (GVP) while optimizing operational efficiency. Their technical proficiency was particularly evident during the successful migration of legacy data to the new safety database. This was executed with precision, maintaining data integrity and minimal disruption to ongoing safety reporting. The Inspector highlighted this during the closing meeting, commenting on how impressed they were with this complex migration strategy and execution.

Med Communications played a critical role in setting up our new pharmacovigilance database, configuring workflows, user roles, and reporting functionalities in full alignment with regulatory expectations. Their attention to detail and proactive communication facilitated a smooth transition and enhanced our overall compliance infrastructure.

Their contribution during our EMA audit was invaluable. The team provided thorough documentation, responded to every request quickly, and offered expert guidance on inspection readiness. Their support was instrumental in helping us navigate the audit process with confidence and ultimately achieve a positive outcome.

I highly recommend Med Communications to any organization seeking a reliable, knowledgeable, and results-driven partner in pharmacovigilance services. Their commitment to excellence and deep understanding of regulatory requirements set them apart in this highly specialized field.

We’re here to help if you are experiencing this same issue. Contact us today to request a capabilities presentation: 877-477-0977 or https://medcommunications.com/contact-us/.