At Qualigence Health , we are determined to solve your consulting needs in Drug Safety, Regulatory Affairs and Validation. We help our clients implement the right strategic solution as we constantly study emerging best practices, in local and global regulations. The ethos of Qualigence is about providing Quality driven Vigilance in an efficient and cost effective manner. At Qualigence Health, we combine the strength of our expertise, experience and high quality deliverables to advance clinical development, market access and post-approval support to the Pharmaceutical and Medical Device industries.
Pharmaceutical companies must move to a more efficient, strategically focused PV capability in order to be less reactionary, resource-intensive, and transaction focused, and become instead a more proactive agent for patient safety.
Managing your individual case safety reports (ICSR's) accurately and efficiently is critical to an effective PV system.
We can handle all your Aggregate Safety Reporting obligations throughout the life-cycle of your product.
From keeping tabs on adverse events in EudraVigilance to helping your organization follow Good Pharmacovigilance Practices (GVP), our team members will help you follow the right regulatory guidelines.
An effective Risk Management System and the development and update of Risk Management Plans, mandatory in the EU, are a critical part of pharmacovigilance and patient safety
Our full range regulatory affairs solutions and services are dedicated to delivering the highest quality support, assistance and regulatory approvals.
Qualigence Health delivers top-quality validation solutions and remains core focus of our Professional Services consulting division, which serves the pharmaceutical, medical device, biotech, animal health, cosmetic, and tissue industries.