Medical Writing Services

We cover regulatory, clinical, nonclinical, safety, and scientific writing. This includes clinical study reports, eCTD Modules 2 to 5, IND and NDA applications, MAA dossiers, protocols, investigator brochures, patient safety narratives, integrated summaries, PSURs, PBRERs, DSURs, risk management plans, and scientific publications.

Yes. Our writers deliver CSRs to ICH E3, meeting FDA, EMA, and MHRA expectations for structure, content, and consistency with the underlying clinical database.

Yes. We author Modules 2.4 (Nonclinical Overview), 2.5 (Clinical Overview), 2.6 (Nonclinical Written and Tabulated Summaries), and 2.7 (Clinical Summary), and support Modules 4 and 5 study reports and appendices.

Yes. We prepare PSURs, PBRERs, DSURs, EU RMPs, PSMF content, and individual case safety narratives under GVP. Our writers work with pharmacovigilance auditors and QPPVs in the same team.

For a defined scope we can typically mobilise experienced writers within a week. Rapid deployment is available for submission-critical timelines.

Yes. We provide project-based writing, embedded writers who sit inside client teams, and interim medical writing leadership depending on your resourcing needs.

Oncology, rare disease, immunology, CNS and neurology, cardiovascular, infectious disease, respiratory, and metabolic disease, including ATMPs (gene and cell therapy) and vaccines.

Yes. We author across pharma, biotech, and medical device programmes, including CERs, CEPs, PERs, PMS reports, PMCF plans, IFUs, and regulatory documents for CE marking, UKCA, and FDA 510(k) and PMA submissions.