We Maximize Our Expertise to Minimize Your Risk.
We’ve been where you are — at pharmaceutical and biotech companies around the world. We are engineers and chemists, project managers and systems analysts, trainers and subject matter experts. Through our experience in pharmacovigilance operations, quality and technical system administration, we know the role pharmacovigilance reporting and compliance play in your company’s success. Today, we apply our understanding of your business processes to optimize your drug safety software solutions.
When you employ Covigilant’s customized drug safety compliance solutions, you’ll increase your data consistency and accuracy, gain operational efficiencies, improve your audit readiness and — most importantly — mitigate compliance risks throughout the life cycle of your product. We bring you peace of mind through:
Drug Safety Compliance Expertise
With decades of experience in pharmaceutical operations, quality assurance and technical system administration, we offer customized, fully validated, 21 CFR Part 11/Annex 11-compliant software solutions. Leverage our expertise in pharmacovigilance database management and global regulatory compliance to maximize the benefits of your solution.
We support you every step of the way, from initial validation and implementation of your safety system to filing your first periodic report to providing guidance during regulatory inspections. Day to day, you’ll have service you can rely on — in hours, not weeks. We’ll be there, on site if you need us, to support your drug safety compliance through your product’s life cycle.
Flexible Pricing Options
We offer flexible options to ensure that you get the most value per dollar based on your unique business needs. For clients that anticipate a small number of required system changes and analytic support, time and materials pricing may be the most cost-efficient model for you. For clients that anticipate larger volumes, or that wish to have one static cost for budget planning, our fixed-pricing model includes unlimited system changes and analytics.
Our name tells our story: Covigilant partners with you to watch over your drug safety compliance. We protect your product. We protect you. And by mobilizing our experience and expertise to solve your most critical pharmacovigilance challenges, we protect your future. We are your drug safety experts.
Covigilant’s capabilities in delivering drug safety solutions are made possible by the relationships we’ve built. As an Oracle Gold Partner, we develop and implement products and services across Oracle’s entire Argus portfolio, including database and server systems that provide complete pharmacovigilance solutions.
Covigilant has partnered with Rackspace, the leading managed cloud provider, to host our Argus Safety infrastructure. With global data centers, military-grade cybersecurity and 24/7 customer support, Rackspace ensures that our clients enjoy maximum system uptime and data integrity in their pharmacovigilance solutions.