Regulatory Writing
Regulatory Writing Services
Med Communications offers regulatory writing support across all stages of clinical drug development. Tap the blue boxes to learn more.
Med Communications’ regulatory writing team brings experience and quality to every client and every project. Whether you need support for a single document or an entire program, our scientist-writers work as an integrated part of your team to develop content tailored to your regulatory needs and according to your deadline. We offer functional service provider, hourly, or project-based engagements.
Strategic Consulting
Our regulatory writing team has broad regulatory document and therapeutic area expertise. We understand the regulator’s approach to document review and how that aligns with lean authoring principles. We can help guide your team to produce concise and compliant regulatory documents. Med Communications also offers “rescue regulatory writing” services when your current vendor isn’t providing the level of quality or service that your team requires.
Project Management
At Med Communications, we know that content is only one step on the road to success. Our regulatory writers have the organizational, communication, and collaboration skills required to guide your project from planning to completion.
- Timeline development: Our writers will collaborate with your team to develop timelines that meet your deadlines and accommodate the conflicting demands on their time.
- Individual document management: Our writers will shepherd your document from kickoff meeting through finalization and internal approval. We will follow your process or share our own best practices.
- Submission management: Our experienced regulatory writers can help develop timelines to facilitate parallel, coordinated development of pivotal clinical study reports, Module 2.7 summaries, and Module 2.5, while ensuring alignment across documents.