Joe Collis is an independent consultant providing regulatory medical writing services to biopharmaceutical and biotechnology companies. He prepares clinical and regulatory documents for drugs, biologics, and advanced therapies to support clinical studies and health authority submissions in various markets.
Fundamentals of regulatory writing: the document development process
Regulatory writers lead the development of high-quality regulatory documents by working in collaboration with colleagues across multiple functions. Document development is a multistep process with the regulatory writer acting as project leader. This article describes each of the stages of the process and suggests best practices for achieving timely project completion and document delivery