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Expert Medical and Regulatory Writing Services
Ensure clear, compliant, and impactful documentation with our expert medical writing support for regulatory submissions, clinical study reports, and scientific communications.
Medical Writing for Regulatory Compliance and Scientific Communication
High-quality medical writing is essential for ensuring regulatory compliance and effectively communicating scientific research to diverse audiences. When medical writing lacks clarity, it can lead to misinterpretation of data, potentially resulting in poorly informed development decisions.
At Cytel, our Senior Medical Writers bring over a decade of industry experience and a deep knowledge of ICH-GCP guidelines, regulatory requirements, and diverse therapeutic areas, including oncology, virology, gastroenterology, neurology, inflammation, and vaccines.
We specialize in delivering accurate, compliant, and tailored medical writing for a wide range of projects and indications.
Seamless Execution
Our medical writers combine subject matter expertise with strong project management skills for efficient planning and seamless execution, independently or within multidisciplinary teams.
Comprehensive Document Support
We develop clinical summary documents, annual reports (DSUR), IB updates, SAE narrative writing, and publications.
High-Quality Outputs
Our medical writers collaborate closely with statisticians and programmers to ensure accurate data presentation, including high-quality programmed tables, figures, and optimized SAE narratives.
Breadth of Experience
With hundreds of Clinical Study Reports (CSRs) and Clinical Study Protocols authored, we support studies across most therapeutic areas and all clinical trial phases.
Tailored Medical Writing for Regulatory Authorities, Physicians, and Patients
Effective medical writing must be clear, accurate and audience specific. Whether for regulatory authorities, physicians, or patients, each document must balance scientific depth with readability.
Our expert team ensures regulatory compliance, engagement, and precision, aligning content with global industry standards.
Regulatory Writing Expertise for Successful Submissions
A precise understanding of regulatory guidelines and therapeutic area-specific requirements is crucial for successful product authorization. Cytel’s expert medical writers help you navigate these regulatory and industry challenges with confidence, ensuring submissions meet the highest standards for successful approval.
Cytel’s medical writers prepare study and regulatory documents, including but not limited to:
- Study Protocols
- Patient information and Informed Consent Form (ICF) and clinical trial summaries (Lay Summaries)
- Investigator Brochures (IB)
- Study reports (CSR)
- Marketing Authorization Applications (MAA)
With our extensive experience in regulatory writing for clinical trials and drug development, we ensure submission-ready documents that meet stringent EMA, FDA, and global standards.
100+
Developed hundreds of Clinical Study Reports (full and abbreviated)
I-IV
Experience across all clinical trial development phases
10+
Senior Medical Writers with more than a decade of industry practice
Claim your free 30-minute strategy session
Book a free, no-obligation strategy session with a Cytel expert to get advice on how to improve your drug's probability of success and plot a clearer route to market.
