Westat’s medical writers develop accurate, complex dossiers that adhere to regulatory requirements.

Dossiers

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

Documents

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
• Protocols
• 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.

Document Quality

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.

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