Lucore-Regulatory

Regulatory Consulting for Biotech and Pharmaceutical Innovators

Navigating global regulatory complexity with clarity and precision, Lucore-Regulatory provides strategic guidance and operational support from pre-clinical through post-market.

Who We Are

We provide expert regulatory strategy, submission support, and authority engagement services tailored to your product lifecycle.

Whether you're preparing an IND, coordinating with FDA or EMA, or need post-market compliance support, we deliver clear, actionable regulatory solutions that reduce risk and accelerate time to market.

Leadership

Core Capabilities

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Development Strategy

Customized regulatory roadmaps aligned with global authority expectations.

Submission Planning

Comprehensive support for IND, CTA, BLA, NDA, and MAA submissions.

Medical Writing

Authoring of protocols, briefing books, regulatory dossiers, and CTD modules.

Need Regulatory Guidance?

Let’s explore how Lucore-Regulatory can support your development and compliance goals.