At Globyz, we specialize in delivering end-to-end regulatory-compliant medical writing services designed to accelerate and optimize the drug development process. Our expert team provides comprehensive support across all phases of clinical research, from initial protocol development through post-market surveillance. With deep expertise in therapeutic areas including oncology, rare diseases, neurology and medical devices, we craft precise, submission-ready documents that meet stringent ICH, FDA and EMA requirements.
Our global team of multilingual medical writers ensures seamless communication and regulatory compliance across international markets. Whether you need clinical study reports, scientific publications, or real-world evidence generation, Globyz delivers the strategic medical writing support you need to bring therapies to market faster and with confidence.
Our Core Services:
Regulatory Medical Writing
Clinical Trial Documents: Protocols, Clinical Study Reports (CSRs), Investigator’s Brochures (IBs), and Informed Consent Forms (ICFs).
Submissions: IND/CTA, NDA/BLA, eCTD modules, and safety reports (DSURs, PSURs).
FDA/EMA Compliance: Adherence to ICH guidelines.
Scientific Communications
Manuscripts, abstracts, posters, and lay summaries for journals/conferences.
Medical education and marketing content for HCPs and payers.
