Newsletter pharma July 2024

Dear reader,

Welcome to another edition of our pharma newsletter!

From client success stories to whitepapers on compliance and quality in pharmacovigilance or the key role of Regulatory Affairs in the pharmaceutical industry, we’ve got a wealth of pharma knowledge to share in this month's issue.

Whether you’re looking to enhance your pharmacovigilance practices and Drug Safety Department or explore the latest industry trends, there’s something for everyone.

Happy reading, and I wish you all a wonderful summer holiday period! We'll be back with fresh content at the end of August.

Antonio Borregon?

Head of Global Business Development Pharma

OUR TOP DOWNLOADS

Ensuring compliance and quality in Pharmacovigilance

The whitepaper emphasizes the importance of a robust pharmacovigilance Quality Management System (QMS) and a well-maintained Pharmacovigilance System Master File (PSMF) detailing system structure, processes, and responsibilities.

The key role of Regulatory Affairs in the pharmaceutical industry: from drug development to commercialization?

This document will give you a better understanding of the role of Regulatory Affairs in the pharmaceutical industry at large and the functions that Regulatory Affairs teams can provide in the lifecycle management of your pharmaceutical product.

CLIENT SUCCESS STORIES

Ensuring Pharmaceutical Production Quality: Cleaning Validation for Government Agency

A longstanding client previously utilizing our Risk-Based Environmental Monitoring (RRAA) services, sought our expertise for their Cleaning Validation initiative across their production lines. This comprehensive project included everything from toxicological evaluations to quality documentation, with both our toxicology and quality assurance departments involved.

Read more

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Revolutionizing Pharmacovigilance: A Success Story of Strategic Partnership and Seamless Integration

A Spanish generic pharmaceutical company, with 90 products currently on the market, reached out to us to outsource all their pharmacovigilance (PV) activities. They required a Quality PV, but lacked the time to manage it themselves. Curious to know more about the challenges, approach, and successful outcome of this client case??

Read more

CHANGING THE PARADIGM STRATEGY IN YOUR DRUG SAFETY DEPARTMENT

The QbD Group is a leading provider of comprehensive pharmacovigilance (PV) outsourcing services. We understand that your needs are unique, which is why we're excited to introduce ONE Vigilance, our innovative and affordable next-generation biopharmacovigilance solution.

?What is ONE Vigilance?

• Unified, global, and centralized outsourcing: We offer a single point of contact for all your global PV needs, ensuring consistency and streamlined processes.
• Alignment with your goals: ONE Vigilance is designed to align with your corporate objectives, as well as the needs of prescribers and patients.
• Top-down strategy for tailored partnerships: We employ a comprehensive approach that synchronizes global and local requirements. This allows us to build outsourcing partnerships that meet your specific regional needs.

Why choose ONE Vigilance?

Finding the right partner is crucial for maximizing the benefits of outsourcing biopharmacovigilance. QbD Group offers the expertise and experience you need, along with:

• Scalable FTE solutions: We adapt our resources (Full-Time Equivalents) to your business cycles, improving process times and talent management while maintaining accountability.
• Cost-effective approach: We deliver optimal pricing and cost-effective solutions for your PV needs.
• High-quality, fast results: You can expect high-quality solutions delivered with speed and efficiency.
• Data-driven insights and customer focus: We measure impact, prioritize customer satisfaction, and understand the social networking landscape to better serve you.
• Predictive analytics with AI: ONE Vigilance leverages digital innovation, real-time data, and AI-powered analytics to offer predictive, proactive, and personalized services.

??Learn more about how ONE Vigilance can help you achieve corporate excellence. Download our whitepaper, "The ONE Vigilance Strategic Roadmap to Corporate Excellence."

OUR MUST-READS

THOUGHT LEADER'S OPINION PIECE

Revolutionize Your Drug Safety Department

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The landscape of drug safety is shifting. We're at a crossroads: hold onto outdated routines or embrace change that unleashes the true potential of your team.

Imagine a drug safety department not bogged down by paperwork, but fired up to identify risks, analyze data for groundbreaking insights, and implement innovative safety measures. This is the future you can create by strategically outsourcing operational tasks. Think of your team as a powerhouse of expertise. Wasting their talent on repetitive tasks is like using a race car for errands.??

Outsourcing isn't "surrender", it's strategic empowerment. It allows your department to not just keep pace with the industry, but lead the charge in setting new standards for patient safety and regulatory compliance.

It's a transformation that benefits your organization, the industry, and ultimately, the patients. Embrace this transformative journey and see the difference it makes for your organization and the lives you impact. The future of drug safety is here, and it starts with you.?

SEE YOU AT THIS EVENT?

World Drug Safety Congress

9-10 October ?? | Amsterdam, NL ??

Don't miss out on this innovative Safety & Pharmacovigilance event. Connect with the QbD Group as we unlock new possibilities and address key challenges for safety professionals through collaboration, creativity, and excellence. See you at booth 92!

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CPHI Milan?

8-10 October ?? | Milan, IT ??

This year, the QbD Group will be exhibiting at CPHI, which will be held at Fiera Milano. Visit us at booth 18D1 to learn more about our team and services. We will be highlighting our Global-Pharma solutions, including Land in Europe, Lab Services, and the Toxicology area.

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