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E-Book

Complete Guide to FDA Inspection Readiness

Learn how to prepare for an upcoming FDA inspection, what to expect during the inspection, and steps to take following inspection close.

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Blog

Critical Steps for Writing an Impactful Clinical Audit Report

In this blog, we share tips and best practices for writing an impactful clinical audit report.

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Blog

Navigating the FDA Emergency Use Filing Process

Partnering with Advarra, one nonprofit successfully obtained an Emergency Use Authorization from the FDA within five weeks.

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Blog

For FDA Inspection Readiness, Accountability is Key

An Advarra expert provides insight in this Q&A session on the FDA inspection readiness process, including how to improve current workflows.

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3 min. read
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Blog

Q&A: FDA Updates: BIMO – What Sponsors Need to Know

Advarra experts Joan Versaggi and Leslie Paul answer questions from the webinar- FDA Updates: BIMO – What Sponsors Need to Know.

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Blog

Steps to Implementing a Quality Management System

Read our blog to learn more about quality, its role in clinical research, and how to implement a management plan.

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3 min. read
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Info Sheet

ReadyQMS Info Sheet

Advarra ReadyQMS, a quality management system for biopharmaceutical companies, reduces risk and ensures regulatory compliance.

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White Paper

Steps to Implementing a Quality Management System

This white paper outlines the full implementation process of a quality management system and how to avoid conflict by focusing on quality.

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Case Study

Post-Acquisition Risk Assessment

Download the case study to learn more about how Advarra’s experts helped avoid major problems and cost and time challenges.

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Info Sheet

Pandemic Response Assessment

Advarra's pandemic response assessment helps research teams implement large-scale crisis response initiatives in clinical trials.

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