From clinical study reports to global regulatory submissions, ESW Communications delivers scientifically rigorous documentation that meets the highest quality standards.
Discuss Your ProjectESW Communications provides end-to-end medical writing support for pharmaceutical and biotechnology companies. Our experienced team delivers ICH-compliant documents that position your product for regulatory success across global markets.
ICH E3-compliant CSRs for Phase I through Phase IV studies. Complete report development from shell to final, including abbreviated CSRs and amendments.
Learn More →NDA, BLA, and MAA support for FDA and EMA approvals. End-to-end submission writing including CTD summaries, briefing documents, and health authority responses.
Learn More →Clinical overviews and summaries that tell your product's story. Strategic Module 2.5, 2.7, 2.4, and 2.3 documents that frame your entire submission.
Learn More →Clear, compliant safety narratives for regulatory review. SAE narratives, death narratives, and discontinuation documentation that meets regulatory requirements.
Learn More →ISS and ISE documents that synthesize your clinical program. Comprehensive pooled analyses and cross-study presentations of safety and efficacy data.
Learn More →Manuscripts, abstracts, and posters for peer-reviewed journals and medical congresses. Publication support developed to GPP guidelines.
Learn More →We combine scientific expertise with regulatory knowledge to deliver documents that support your path to approval.
Deep knowledge of ICH guidelines and regional requirements for FDA, EMA, and global health authorities.
Experienced writers with advanced degrees who understand your science and can communicate it effectively.
Proven track record of meeting critical regulatory timelines without compromising quality.
From single documents to full program support, scaled to your needs and timeline.
A proven approach to delivering high-quality medical writing
Understanding your requirements, timelines, and strategic goals
Developing document shells, outlines, and writing plans
Writing, internal review, and iterative refinement
Final QC, client review, and on-time delivery
Contact us to discuss your medical writing needs and how we can support your next project.
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