ProPharma

Every patient deserves safe, effective, and timely access to the medicines they need. We partner with life science organizations to ensure product quality, regulatory compliance, and patient safety, at every stage of the development journey. Your mission is our mission: improving patient health and safety worldwide. Learn how we help bring innovations to patients faster: https://lnkd.in/e2jQtmj4.

In today’s data-driven pharmaceutical landscape, patient safety depends on more than vigilance; it demands collaboration. Our experts share how Pharmacovigilance and Medical Information teams can work together to enable early signal detection, faster communication, and stronger regulatory compliance. Read the full article: Improving Patient Health and Safety through Pharmacovigilance and Medical Information Synergy: https://lnkd.in/eUVWKuHt.

The FDA 510(k) submission process demands precision, preparation, and strategy. Yet even experienced manufacturers face challenges navigating new requirements, technical standards, and evolving FDA expectations. Our step-by-step 510(k) checklist helps you organize, anticipate, and respond—minimizing delays while strengthening compliance. From predicate selection and testing strategy to eSTAR and interactive review readiness, it’s your roadmap to a successful clearance. Download the guide: https://lnkd.in/eAfWkqYc.

AI is transforming Medical Information, but with innovation comes responsibility. In this on-demand webinar, Valerie Huh, Director, Global Innovation & Implementation at ProPharma, explores accountability in AI-driven processes, regulatory expectations, and how to maintain compliance and quality as technology evolves. Watch the full replay: https://lnkd.in/eFpSAyt5.

Comprehensive Pharmacovigilance is central to patient safety across the product lifecycle. From proactive monitoring to regulatory insight and risk mitigation, we provide the expertise to support confident program progression. Explore PV insights across the lifecycle: https://lnkd.in/eXQF6-b5. #WeAreProPharma

Selecting the right manufacturing partner can determine whether a product reaches patients on time or misses critical milestones. In our article, we outline a systematic approach to evaluating potential Contract Manufacturing Organization (CMO) partners, focusing on aligning technical capabilities, audit history, technology transfer readiness, and commercial scale potential. Using our proprietary CMO Compass tool, we guide you through the five key steps that reduce risk, improve visibility, and strengthen your supply chain strategy. Read the full piece here: https://lnkd.in/eTUk_EXh.

Driving collaboration and innovation in clinical research. At the AusBiotech International Conference 2025 in Melbourne, Sharon Charles, Vice President of Clinical Operations at ProPharma, chaired a panel with industry leaders for a discussion on “Clinical Trial Start-up and Implementation,” part of “The Australian Advantage: Unlocking Clinical Trials & Contract Manufacturing Excellence” stream. The conversation examined how Australia’s clinical research ecosystem provides international and local Biotechs and Biomedical companies with access to global thought leaders and innovators, as well as opportunities and access to clinical trial start-up speed, quality, and regulatory excellence. It also explored how collaboration throughout the development pipeline enhances access to life-changing therapies. #WeAreProPharma #AusBiotech2025

Accurate, compliant medical information is central to patient confidence and regulatory trust. In the Netherlands, where oversight from the Medicines Evaluation Board (CBG-MEB), the Code of Conduct for Pharmaceutical Advertising (CGR), and EU legislation define strict parameters for communication, Medical Information (MI) teams play a vital role in ensuring that healthcare professionals and patients receive unbiased, factual responses. Our article examines how effective MI operations ensure compliance, support pharmacovigilance and quality systems, and lay the groundwork for responsible engagement throughout the product lifecycle. Read more: https://lnkd.in/ec3ZAEkm.

Medical, Legal, and Regulatory (MLR) submissions are essential for ensuring compliant promotional materials—but they often become sources of bottlenecks and conflicting feedback. Our blog outlines how to build a more efficient, compliant MLR submission process, from organizing content and substantiating claims to managing version control and review timelines. Discover practical strategies to streamline collaboration, reduce rework, and achieve faster, more consistent approvals. Read the full blog: https://lnkd.in/engn-2gV.

In her latest feature, “The Relevance of AI in Medical Information: Transforming Communication, Compliance, and Care,” Kirsty Bryant examines how artificial intelligence is revolutionizing the way life sciences organizations communicate, ensure compliance, and promote patient well-being. She highlights how AI, when applied responsibly, enhances precision, accelerates insights, and strengthens the human connection that defines effective healthcare communication. Read the full article in PIPA - Pharmaceutical Information and Pharmacovigilance Association's publication: https://lnkd.in/ePEW7twF. #WeAreProPharma