Westat’s professional medical communicators develop accurate, complex publications and dossiers that are scientifically and ethically sound, compliant, and keyed to the right target audience.
Westat’s medical writers develop accurate, complex dossiers that adhere to regulatory requirements.
Westat’s medical writers collaborate with external clients, subject matter experts, and internal scientific staff to develop the following regulatory dossiers (Modules 1-5) for submission to the US Food and Drug Administration and other regulatory oversight authorities:
- Investigational New Drug applications
- New Drug applications
- Biologics License applications
Individual dossier documents require advanced word processing, formatting of tables and graphics, indexing, and pagination using specific electronic Common Technical Document (eCTD) templates and according to oversight regulations. These documents include, but are not limited to, the following:
- Meeting packages
- Responses to requests for information
- Informed consent forms
- Investigational brochures
- Clinical study reports
Collaborative Document Authoring
Westat medical writers have extensive experience in leading multidisciplinary writing teams that include clinicians, sponsor representatives, statisticians, data managers, safety reviewers, and publishers. They are adept at providing document writing and review timelines and budget estimates to ensure the delivery of high-quality documents within established deadlines.
The expertise of Westat medical writers lies in writing, editing, and reviewing documents, emphasizing content, structure, consistency, clarity, quality, and adherence to regulatory guidelines and eCTD dossier submission requirements. They also ensure version control through the use of secure and compliant electronic document management systems.
With decades of experience, the Westat medical writing team has the knowledge required to support client efforts in drug, biologic, and medical device development.
Featured Therapeutic Areas
Related Team Members
Senior Study Director
Julia Solarczyk Donnelly
Regulatory Affairs Lead