About Lareau Consulting
What I do
Over the past 21+ years I’ve led regulatory document development, as well as medical and regulatory-writing teams that carried 30+ IND, NDA, and BLA dossiers from blank page through agency submission. I’ve created templates used by top-10 pharma, built teams and processes from Day 0 through on-time BLA submission, and steered cross-functi
Over the past 21+ years I’ve led regulatory document development, as well as medical and regulatory-writing teams that carried 30+ IND, NDA, and BLA dossiers from blank page through agency submission. I’ve created templates used by top-10 pharma, built teams and processes from Day 0 through on-time BLA submission, and steered cross-functional authoring sprints. My track record is simple: submissions land on time, audit findings stay minimal.
Today, I function as either:
- a Principal Writer who delivers high quality documents quickly or
- in a fractional leadership role—plugging in as a Head of Medical/Regulatory Writing for biotech and mid-size sponsors who need senior oversight but not a full-time salary line. I centralize SOPs, mentor in-house writers, and implement lightweight automations that cut review cycles by 30 percent
Known for being highly responsive and easy to work with, I make collaboration seamless and efficient from Day One.
I look forward to meeting you and your team!