Addison Avery Regulatory Consulting

About Addison Avery Regulatory Consulting

At Addison Avery Consulting, we specialize in global regulatory affairs strategy, regulatory project management, and due diligence for the pharmaceutical and biotech industries. Founded by seasoned regulatory experts with over 25 years of experience, our firm partners with life science innovators to navigate complex global regulatory pathways from early development to approval and beyond. Our team has led successful IND, NDA, BLA, CTA, and EU CTR submissions across therapeutic areas including oncology, neurology, hematology, immunology, and rare/orphan diseases. We’ve supported everything from first-in-human studies to late-phase development and post-marketing lifecycle management, collaborating closely with FDA, EMA, and global Health Authorities. In addition to regulatory strategy and execution, we offer robust regulatory project management, building and maintaining detailed timelines, dashboards, and cross-functional workflows to keep programs on track and aligned with corporate milestones. We also provide regulatory due diligence support for mergers, acquisitions, and licensing evaluations, offering clear assessments of regulatory history, risk, and opportunity. But what truly sets Addison Avery apart is our foundation. The firm is named in honor of Addison, founder Jenna Arnold’s first Golden Retriever, whose loyalty, calm presence, and unwavering dedication inspired the values that guide our work today: trust, integrity, precision, and partnership. At Addison Avery, we don’t just consult, we integrate, align, and deliver. Whether you're a startup preparing for your first submission or an established company seeking expert guidance, we bring clarity, strategic insight, and hands-on leadership to help you bring therapies to patients faster, smarter, and with confidence. Addison Avery: Trusted regulatory support, with golden standards.

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