Meet the Team!
Catherine Lareau, MS
Catherine Lareau, MS
Catherine Lareau, MS
Catherine, the founder and owner of Lareau Consulting, has 20+ years regulatory/medical writing experience; 23+ years biomedical writing. In the past, she has served as President and on the Board of Directors for her local chapter of the American Medical Writers Association (AMWA).
She has worked with CROs, Big Pharma, as well as midsized
Catherine, the founder and owner of Lareau Consulting, has 20+ years regulatory/medical writing experience; 23+ years biomedical writing. In the past, she has served as President and on the Board of Directors for her local chapter of the American Medical Writers Association (AMWA).
She has worked with CROs, Big Pharma, as well as midsized and start-up life science companies, writing their clinical- and FDA-facing documents. As Principal Writer, she has authored a wide range of documents across the full span of the drug development life cycle.
Catherine holds an MS in Epidemiology from the University of Virginia and a BA in English from the College of William
and Mary.
Catherine’s document authoring experience includes: INDs and NDAs, including BLAs, MAAs, 505(b)(2), sNDAs, ANDAs (Modules: 2.2: Introductions; 2.5: Clinical Overviews; 2.7s: 2.7.1-2.7.6; 5.3.5.3: ISIs, ISSs, ISEs, and Extrapolation); literature reviews, briefing books, regulatory responses; annual reports, DSUR, PBRER, PSUR, clinical protocols, Investigator’s Brochures, CSRs, CDPs,
manuscripts; pediatric study plans, package inserts, physician guidances, product labeling, REMS, RMPs, clinical outcome assessments (COA) dossiers (PRO and ClinRO), and patient safety narratives.
Hailey Johnson
Catherine Lareau, MS
Catherine Lareau, MS
Hailey graduated magna cum laude from
James Madison University, in Writing, Rhetoric & Technical Communication with a scientific writing concentration. Her precision and understanding of science and the regulatory processes make her an invaluable editor and writer.
Hailey has interned and worked for Lareau Consulting for 3 years.
Hailey has
Hailey graduated magna cum laude from
James Madison University, in Writing, Rhetoric & Technical Communication with a scientific writing concentration. Her precision and understanding of science and the regulatory processes make her an invaluable editor and writer.
Hailey has interned and worked for Lareau Consulting for 3 years.
Hailey has acted as Catherine’s righthand person for some time now. She authors and edits templates for protocols, CSRs, and IBs. Her fundamentals are strong, and she does a mean QC.
Scott Gilman
Catherine Lareau, MS
Scott Gilman
Scott graduated magna cum laude
from USC with a writing concentration. His eye for detail and quick understanding of science and the regulatory processes make him an invaluable editor and writer.
He has interned and worked for Lareau Consulting for 2 years.
Scott’s stable of documents includes
protocols, CSRs, literature reviews, SOPs, QC of clinical NDA modules, and consistency editing.
Our Helpers on the Home Front
Lulu and Jasper
Lulu and Jasper
Lulu and Jasper
Lulu and Jasper enjoy reminding Catherine that there is a happy squirrel population on the other side of the glass door and show an active interest in the family’s free-range chicken, Peaches. Napping and listening to Catherine’s husband play piano and sing round out their hobbies.
Marcy
Lulu and Jasper
Lulu and Jasper
Marcy, who was found under the hood of
Hailey’s car on her engine, was a gift from the cat distribution system. She is too young to have developed many bad habits but delights in pulling apart the screws of Hailey’s bed. She has tremendous potential.