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White Paper

Rare and Orphan Diseases: Choosing a Path to Regulatory Approval and Market Success

Explore the regulatory challenges and pathway guidance for sponsors bringing innovative rare and orphan therapies to market.

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Blog

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.

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Blog

Regulatory Considerations for Pharmaceutical Product Lifecycle Management

New FDA guidance (ICH q12) applies to pharmaceutical drug substances and products requiring a marketing authorization.

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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.

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Webinar

The IND Journey Phase I – Navigating Success

Explore strategies for advancing investigational new drug (IND) submissions and a comprehensive guide through Phase I of the IND journey.

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Case Study

GDPR Implementation Support

Learn how Advarra’s global consulting expertise enabled iSpecimen to implement GDPR with no service interruption to their customers.

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Blog

Pitfalls of Chemistry, Manufacturing, and Controls in Investigational New Drug Preparation

Submitting an Investigational New Drug (IND) application for the first time? Consider three common CMC pitfalls that may impact submission.

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Blog

Good Manufacturing Practices (cGMP): When Do They Apply?

When do current Good Manufacturing Practices (cGMP) regulations apply? Read more for FDA expectations for the application of cGMP to investigational drugs:

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Blog

Keep in Touch: Tips for Working with a Single IRB for the First Time

Recent regulations and policies have many institutions establishing policies and processes for working with an external sIRB. Read more:

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Blog

Q&A – Ask Advarra Live: The Real-World Impact of COVID-19 on Research

We have addressed the most popular Q&A topics from our recent webinar on the research impact of COVID-19 in this blog post. Read more:

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Blog

Differentiating “Public” and “Private” Internet Spaces in IRB Review

The difference between “public” and “private” internet spaces has gained importance with the growing research use of internet and social media platforms as data sources. Read more:

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Blog

Meeting the Challenges of Investigator-Initiated Trials

How does investigator-initiated research differ from other types of clinical research? Advarra IRB Chairperson Robert Romanchuk explains.

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