Services in Focus series: Regulatory Writing

Med Communications’ newest service area, Regulatory Writing, offers support across all stages of clinical drug development:

• Clinical Trial Protocol Development
• Investigator’s Brochures
• Clinical Study Reports
• Submission Support
• Quality Control
• Safety Narratives
• Aggregate Safety Reports
• Clinical Trial Publications

Under the leadership of department director Ann Winter-Vann, who has more than 18 years of experience with regulatory writing, our team provides the support you need to produce concise, compliant regulatory documents. Our scientist-writers collaborate seamlessly with your organization to craft content tailored to your regulatory requirements and timelines. With extensive expertise across various regulatory documents and therapeutic areas, we have a deep understanding of the regulatory approach to document review and how it integrates with lean authoring principles. We also provide “rescue regulatory writing” services if your current partner falls short of the quality and service levels you require.

We recognize that content is just one aspect of achieving success. Our regulatory writers possess the organizational, communication, and collaborative skills necessary to manage your project from inception to completion. Our comprehensive services include timeline development, individual document management, and submission management to ensure all your regulatory needs are met effectively.

We offer flexible engagement models, including functional service provider arrangements, hourly rates, and project-level contracts, to best meet your company’s needs. Contact us today to explore how we can support your regulatory writing needs: 877-477-0977 or https://medcommunications.com/contact-us/.