What we do

Leiam provides senior regulatory and development advisory support to biotech teams facing critical inflection points — from early clinical planning to regulatory strategy and submission readiness.

Engagements are typically short, focused, and led directly by an experienced regulatory and development leader, with the goal of enabling confident decisions and de-risking regulatory pathways.

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Core Focus Areas:

• Asia-Pacific Regulatory Strategy

Regulatory positioning and strategy for programs targeting Singapore (HSA) and APAC markets, including CTA readiness and agency engagement planning.

• Development–Regulatory Integration

Aligning clinical, nonclinical, and CMC plans with regulatory expectations to support efficient development and future market differentiation.

• Regulatory Strategy for Novel Modalities

Early regulatory thinking for non-traditional or emerging drug formats, including pathway assessment and risk identification.

• Submission & Dossier Readiness

Strategic input into submission structure, content expectations, and regulatory storytelling — not document publishing.

• Independent Regulatory Sounding Board

Senior regulatory perspective for founders, CSOs, and development leaders who need a trusted second view before key decisions.