Nellie Forwood

Ms. Forwood has over 30 years of experience in the pharmaceutical and other regulated products industry (pre- and post-approval) as a clinical and chemistry, manufacturing, and controls (CMC) Regulatory Affairs Professional. She is a certified Six Sigma Master Black Belt with proven expertise in the use of Six Sigma Define, Measure, Analyze, Improve, and Control tools to improve processes and implement and maintain improvements.

As an Associate Director, Regulatory Writing, Ms. Forwood has written several types of pharmaceutical CMC and clinical regulatory documents. She has experience in documentation preparation for pre-regulatory meeting briefing documents, Investigational New Drug Applications (INDs), Investigational Medicinal Product Dossiers (IMPDs), New Drug Applications (NDAs), and Marketing Authorisation Applications (MAAs) for large and small molecules with emphasis on regulations and electronic Common Technical Document (eCTD) requirements. Ms. Forwood also has experience in writing Clinical Study Protocols (CSPs) and amendments, Investigator’s Brochures (IBs), briefing documents, and pharmaceutical CMC (Module 2.3 and Module 3) submission documents for different therapeutic areas.