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Blog

Good Manufacturing Practices: When Do They Apply?

Ensure product quality and compliance in the drug development process. Learn how to optimize your manufacturing processes and maintain key regulatory standards with cGMP best practices from experts.

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Blog

The Regulatory Binder Checklist For Clinical Trial Sites

This checklist offers a comprehensive framework for managing all necessary essential regulatory documents efficiently.

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5 min. read
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Webinar

Don’t Get Caught Off Guard: Inspection Readiness for Sponsors and CROs

Discover strategies for proactively assessing compliance for an FDA Inspection Readiness visit. Address deficiencies and implement corrective actions.

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Blog

Top 3 Reasons Why Your Medical Device Needs a Clinical Trial

Interpreting evolving regulations for medical devices is a common challenge for emerging biotech companies.

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Blog

FDA Guidance Offers New Flexibility to Biotechs in Cell and Gene Therapy

FDA recently released new guidance, potentially impacting early-phase cell and gene therapy trials.

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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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3 min. read
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