Clinical Regulatory Writing Services
At Med Communications, our team of experienced medical and regulatory writers supports clinical development and documentation for a wide range of companies, including medical device, biotechnology and pharmaceutical businesses. We create accurate, compliant and submission-ready documents with an eye toward scientific integrity and global regulatory guidelines.
Whether you need early-phase protocol documents or pivotal study reports, our clinical regulatory writing services can help you clearly communicate results and advance your products toward approval.
Our Clinical Regulatory Writing Services
Our clinical writing team delivers documentation to support your clinical studies and regulatory applications. We understand the complex requirements of health authorities like the Federal Drug Administration (FDA) or the European Medicines Agency (EMA.
We can create precise, audit-ready reports and documents, such as:
- Clinical study reports (CSRS). Our team can create comprehensive CSRs for Phase 1 through Phase 4 clinical trials, including pivotal, interim and final reports that meet ICH E3 and other applicable guidelines.
- Abbreviated and synoptic reports. We can also write concise summaries that provide clear, data-driven overviews of study outcomes for internal review or regulatory submission.
- CSR supporting documents. We’ll work with you to create appendices, patient narratives, statistical analysis plans and other materials required to complete your submission package or backup your reporting.
- Protocols and protocol amendments. Our experienced team creates regulatory-compliant, scientifically sound clinical trial protocols that help you set the foundation for successful clinical trials.
Our writers have extensive experience in delivering well-balanced documents across a wide variety of regulatory and clinical writing, including safety narratives, submission support and investigator’s brochures.
Schedule a Consultation
Contact Med Communications to discuss your clinical regulatory writing needs. Our expert team can help you streamline your documentation process and ensure compliance with regulatory guidelines. We partner with you for clinical writing processes to support clarity and confidence as you move toward submission.