Regulatory and Medical Writing Services
Specializing in the delivery of regulatory and medical writing services, including, but not limited to: protocols and amendments, investigator’s brochures, clinical study reports, patient discontinuation and safety narratives, regulatory submission deliverables, as well as posters, abstracts, and manuscripts.
Testimonial
"...Thanks to Marisa’s attention to detail and careful work by the entire team, there were no questions from regulators on the associated sNDA."
Claire McCall, Associate Director of Medical Writing, Genzyme