Navigating global regulatory complexity with clarity and precision. Lucore-Regulatory provides strategic guidance and operational support from pre-clinical through post-market.
Lucore-Regulatory is a trusted consulting partner for biotech and pharmaceutical companies navigating global regulatory landscapes. With deep industry experience and scientific insight, 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.
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Customized regulatory roadmaps aligned with global authority expectations.
Comprehensive support for IND, CTA, BLA, NDA, and MAA submissions.
Authoring of protocols, briefing books, regulatory dossiers, and CTD modules.
Let’s explore how Lucore-Regulatory can support your development and compliance goals.