x
Advarra

Community

Advarra Clinical Research Network

Onsemble Community

Diversity, Equity, & Inclusion

Participants & Advocacy

Advarra Partner Network

Community Advocacy

Sign up for the Site-Sponsor Consortium Newsletter

Reviews

Institutional Review Board (IRB)

Institutional Biosafety Committee (IBC)

Data Monitoring Committee (DMC)

Endpoint Adjudication (EAC)

Consulting

GxP Services

Research Compliance & Site Operations

Professional Services

Coverage Analysis​

Budget Negotiation​

Calendar Build 

Technology Staffing

Training

Clinical Research Site Training

Research-Ready Training

Virtual Investigator Meetings

Custom eLearning

Services for

Sponsors & CROs

Sites & Institutions

BioPharma & Medical Tech

Oncology Research

Decentralized Clinical Trials

Early Phase Research

Research Staffing

Cell and Gene Therapy

Ready to Increase Your Research Productivity?
Get a Quote
View All Services

Solutions for Need

Clinical Trial Management

Clinical Data Management

Research Administration

Study Startup

Site Support and Engagement

Secure Document Exchange

Decentralized Clinical Trials

Oncology Research

Early Phase Research

Research Site Cloud

Solutions for Sites

Enterprise Institution CTMS

Health System/Network/Site CTMS

Electronic Consenting System

eSource and Electronic Data Capture

eRegulatory Management System

Research ROI Reporting

Automated Participant Payments

Life Sciences Cloud

Solutions for Sponsors/CROs

Unified Trial Acceleration Platform

Center for IRB Intelligence

Insights for Feasibility

IRB Document Sharing
Ready to Streamline Your Clinical Operations Processes?
Get a Demo
View All Solutions

Resource Library

Podcast

Blog

White Papers

View All Resources

Webinars

eBooks

Case Studies

Events

Ask the Experts

Frequently Asked Questions

COVID-19 Support

News

Check out the latest episodes of Advarra in Conversations with..

About Advarra

Careers

Consulting Opportunities

Leadership Team

Our Experts

Accreditation & Compliance

Join Advarra

Learn more about our company team, careers, and values. Join Advarra’s Talented team to take on engaging work in a dynamic environment.

See Jobs

Regulatory Coe

Back to Resources
 
Webinar

Regulatory Pathways: When to Follow a 505(b)(2) or an ANDA

Critical insights and key considerations for selecting the best regulatory pathway to ensure success for new drug application submissions.

Watch Now
Read more
 
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.

Read Now
3 min. read
Read more

Back to Resources

Explore how VERO Biotech leveraged Advarra Consulting to successfully navigate the pathway to FDA approval. Fill out the form below to access the case study:

 

Subscribe to our monthly email

Receive updates monthly about webinars for CEUs, white papers, podcasts, and more.

Subscribe

Advancing Clinical Research: Safer, Smarter, Faster™

Copyright © 2023 Advarra. All Rights Reserved.