Our Expertise || Etra Therapeutics

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The biologic product development framework is complex and challenging. We're here to guide you to succeed.

We provide counsel and critical insights into FDA thinking at every stage of the biosimilar product development process.

We have extensive experience in providing FDA regulatory, product development and quality systems consulting services.

Medical device development and FDA regulatory approval processes are both complex and highly nuanced. We're the experts you want on your team.

Former FDA regulatory expertise for your drug development journey.

A specialized device team awaits your next innovation.

Helping you meet your functional and operational needs.

One team. Multiple business units. Every step of the way.

We'd love to hear from you. Send us a message and we'll respond as soon as possible.