Catherine Lareau, MS

With over 20 years of regulatory and medical writing expertise, I offer deep experience across the full span of drug development. I have  partnered with CROs, top pharmaceutical companies, and emerging biotechs to craft high-impact clinical and regulatory documents tailored for FDA and global health authorities. My portfolio includes INDs, NDAs, BLAs, MAAs, protocols, CSRs, briefing books, safety reports, and more. With an MS in Epidemiology from the University of Virginia and a BA in English from the College of William and Mary, I prioritize scientific rigor and editorial precision.

In my current role, I provide medical writing leadership, including strategy, authoring, review, and vendor coordination for Sponsor documents, including: protocols (Phases 1-4); CSRs (Phases 1-4); safety narratives; Investigator’s Brochure; leading planning of NDA modules (2.5, 2.7.1, 2.7.2, 2.7.4, 2.7.4, 2.7.6, ISS, ISE).

I also have experience with Literature Reviews, Briefing Books, Regulatory Responses; Annual Reports, DSUR, PBRER, PSUR, Investigator’s Brochures, CSRs, CDPs, manuscripts; pediatric study plans, package inserts, physician guidance, product labeling, REMS, Risk Management Plans, SOPs, and clinical outcome assessment dossiers (PRO and ClinRO). My RWD/RWE experience includes designing and authoring ECA and observational protocols and authoring RWD/RWE observational CSRs.