
VigiDirect
Your Compliance Guide
VigiDirect
VigiDirect provides you with a practical, efficient service solution to meeting all pharmacovigilance and medical device vigilance obligations without unnecessary expenses. We focus on ensuring full compliance with EU regulations, offering a transparent service model where you pay only for the activities that you really need.
Pharmacovigilance and medical device vigilance are critical components of ensuring patient safety and defining the risks of medicinal products and medical devices. However, especially for small Marketing Authorisation Holders (MAHs), MAHs with generic products, and medical device manufacturers, establishing and managing pharmacovigilance and vigilance systems can be challenging. The regulatory requirements are complex and mandatory, but that does not mean they should be overly costly or burdensome.
VigiDirect philosophy:
Vigilance is Essential – Regulatory authorities demand strict adherence to Good Pharmacovigilance Practices (GVP) for medicinal products and vigilance requirements under Regulation (EU) 2017/745 (MDR) for medical devices. Non-compliance can lead to serious consequences, including fines, product withdrawals, increased regulatory scrutiny, or reputational damage.
Sharing Our Expertise – We acknowledge the great potential of all pharmaceutical companies, generic product manufacturers, and medical device companies. These businesses bring together talented professionals. While they are true experts in their field, they still find regulatory compliance a demanding challenge. They often just need the right guidance and support to navigate the complexities of regulatory compliance.
Costs Should Be Proportionate to Necessity – While pharmacovigilance is non-negotiable, it should not be more expensive than necessary! Instead of burdening you with excessive (pharmaco)vigilance solutions, we provide a smart, efficient, and cost-conscious approach, ensuring you meet all legal requirements without excessive spending.
Clear Oversight & Transparency – Transparency is at the heart of our service. With us you will keep a clear understanding of which regulatory requirements our solution helps you fulfill, so you can confidently demonstrate compliance and make informed decisions about your pharmacovigilance system. You will always know exactly what you are paying for and why, with no hidden fees or vague services.
Why Choose VigiDirect?
Our solution is designed to fit effortlessly into your existing processes, requiring minimal effort and disruption on your end. Whether you are implementing a (pharmaco)vigilance system for the first time or optimizing an existing one, we provide a step-by-step guidance, clear workflows, and practical tools that make compliance simple. With our structured approach, you can stay focused on your core business while we ensure all regulatory requirements are met efficiently.
Who Are VigiDirect?
We are a team of seasoned professionals, including doctors and pharmacists, who have dedicated our careers to medicinal safety and improving patient treatment. With 20 years of experience in (pharmaco)vigilance and over 30 years in accurate diagnosis and therapy selection, our experts bring deep knowledge and practical insight to ensure compliance and patient safety (more info).