Rare and Orphan Diseases in Regulated Development
In this webinar, gain an in-depth understanding of regulatory and clinical development challenges for rare/orphan diseases.
Setting Yourself up for Success During Investigator-initiated Trials
This eBook shares tips and best practices to guide researchers through the investigator-initiated trial process while staying compliant.
An Evolving Regulatory Environment for Rare and Orphan Diseases
By 1983, only 38 orphan drugs received FDA approval. Since then, the FDA has significantly changed its approach to rare and orphan diseases.
Tips for Accelerating Your Medical Device through the Product Lifecycle
Explore the latest strategies to accelerate your medical device throughout the product development lifecycle.
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.
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.
Introduction to Advarra Consulting
Our experts work directly with your team to accelerate product development & performance, making clinical research safer, smarter, and faster.
Understanding International Data Transfer’s Impact
Read our blog to understand some of the data privacy implications facing international clinical research.
ReadyQMS Info Sheet
Advarra ReadyQMS, a quality management system for biopharmaceutical companies, reduces risk and ensures regulatory compliance.
Data Integrity – It’s All About the Data!
This blog dives into data integrity in clinical research, including how to obtain and maintain data throughout its lifecycle.
Why it is Critical to Have and Enforce a Data Strategy?
Understand a data strategy's role in clinical research and how enforcing one will benefit your studies.
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.