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Our Services
We’re constantly growing and expanding our service options, so if you have something in mind that we don’t yet provide, we’d love to hear about it.
Consultant & Advisory
Next Level Service
Our team of expert consultants are ready to provide strategic, tactical, or advisory support to your projects, plans, and predicaments.
Services include:
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ICSR Management
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Vendor & Alliance Management
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SDEA/PVA Management
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PSMF Management
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Audit & Inspection Readiness
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PV Training
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PV Standards (SOPs) Development
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Quality Management
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QMS Management
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PV Intelligence
Our unique model allows us to function as a global organization with a local presence.
All of our consultants are experts in the field and follow our commitment to Quality and Compliance.
CRO & QPPV Service
Quality and Compliance Guaranteed!
We provide CRO services with an in-house, ICH compliant safety database that has been successfully utilized by existing clients.
Our team consists of experienced PV professionals (no newbies here), fully trained to provide PV services to ensure you are meeting your compliance and quality goals! We utilize an easy to scale model to reduce attrition while maintaining consistency in deliverables.
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QPPV: Our QPPV Consultants are the best in class, with years of experience in the EU and EEA. As independent advisors and consultants, they are ready to support your strategic development!
Our team is ready to handle any size project and is ICROS certified to support your clinical operations and development activities!
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Safety Intelligence Tool
Ensuring compliance through immediate and effective Safety Intelligence search and review tools
Any PV team's most crucial, and often the most burdensome, factor to success is having a reliable, readily available, and accurate understanding of regulatory requirements.
Possibly one of the most regulated GxP fields, PV is constantly evolving and new rules, guidance, regulations are being published by global health authorities on a daily basis.
Are your systems and procedures complying with the current regulatory expectations?
Do you have a system that is reliable and traceable to ensure you have adequate control over your assessments?
How do you ensure you are not missing something?
Our unique, completely customized, and proprietary tool helps teams large and small take control of their Safety Intelligence needs!