Development Strategy
Align product development with global regulatory expectations from early-phase through commercialization.
Submissions & Planning
Lifecycle planning and expert preparation of IND, CTA, NDA, BLA, and MAA submissions.
Medical Writing
Creation of protocols, briefing books, and CTD documentation with scientific precision.
Regulatory Leadership
Interim head of RA or strategic advisory to support regulatory vision and execution.
Regulatory Intelligence
Track global guidance updates and trends to proactively inform decisions.
Authority Meeting Prep
Plan and support FDA/EMA meetings including pre-IND, Type B, Scientific Advice, and more.
IND Applications
Support for IND authoring, compiling, and submission including Module 2/3 content.
Post-Market Activities
Manage regulatory renewals, reporting, and variation submissions.
Team Development
Mentorship, cross-functional training, and leadership for regulatory talent.
Strategic Advisory
Regulatory consultation for boards, investors, and global access strategy.