Regulatory Writing
Regulatory Medical 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.
Schedule Your Consultation
When you need expert regulatory medical writing support, our scientifically trained, industry-experienced PhD, PharmD, and healthcare professionals can lead your team to success. Our medical writers apply their extensive experience to every project, ensuring your clinical development documents are completed on time and meets the highest standards.
From clinical trial applications and investigational new drug applications to marketing applications to the FDA, EMA, and other regulatory agencies, we handle your data, documentation, and confidential information with our comprehensive quality assurance practices. Our systematic approach incorporates quality at every stage — from kickoff to quality control review, finalization, and document approval — while maintaining our commitment to timely delivery through stringent processes established before project initiation.
Our exceptional team also sets us apart, with 31% of our writers having experience across industry, clinical, and academic settings. Whether you need assistance with a drug application or strategies for regulatory compliance, our specialists provide the expertise that regulatory affairs professionals trust.
Our ongoing staff training and continuous feedback loop ensure we remain at the forefront of medical communications, offering a range of services that satisfy regulatory agencies and your business objectives.Don’t let regulatory writing challenges delay your product development timeline. Contact us today and discover how our extensive experience can support your regulatory needs while maintaining the quality excellence that defines our reputation.