Nancy Smith, PhD, RAC
SVP, Medical Writing Services
Nancy has over 14 years of regulatory medical writing experience, during which time she has served as a project manager and/or lead writer for multiple marketing applications (NDAs/BLAs/MAAs). As a member of the Syner-G Executive Leadership Team, she leads the Medical Writing Services group. Her team of experienced medical writers and quality control specialists provide support for a variety of regulatory documents across a wide range of therapeutic areas and all phases of development (including Clinical Study Reports, protocols, Investigational Brochures, safety narratives, and high-level documents such as integrated summaries of safety and efficacy, Module 2 clinical summaries and overviews, and FDA and Advisory Committee briefing documents).
Nancy Smith, PhD, RAC's Recent Articles
Advice for First Time NDA/BLA Submission Teams
Our team of medical writers has worked with many clients on marketing applications (e.g., NDA, BLA, or MAA) across a variety of therapeutic areas. Each submission is a challenge in its own unique way, but we have found that…
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Regulatory Medical Writing: Who is your audience?
Whether it’s a clinical study report (CSR) for a single clinical study or a Clinical Overview that summarizes a complex clinical development program, it’s often best to consider who you’re writing for at the very start of a writing…