Specialized regulatory expertise tailored to the biotech and pharmaceutical development lifecycle.
Align product development with global regulatory expectations from early-phase through commercialization.
Lifecycle planning and expert preparation of IND, CTA, NDA, BLA, and MAA submissions.
Creation of protocols, briefing books, and CTD documentation with scientific precision.
Interim head of RA or strategic advisory to support regulatory vision and execution.
Track global guidance updates and trends to proactively inform decisions.
Plan and support FDA/EMA meetings including pre-IND, Type B, Scientific Advice, and more.
Support for IND authoring, compiling, and submission including Module 2/3 content.
Manage regulatory renewals, reporting, and variation submissions.
Mentorship, cross-functional training, and leadership for regulatory talent.
Regulatory Consulting for boards, investors, and global access strategy.