Our medical writers include members of the American Medical Writers Association and founder members of the European Medical Writers Association, who have benefited from the highly specialised training of these professional organisations.
Our team writes and edits all types of documentation, whether for internal company use, regulatory submission, publication or marketing support.
Regulatory documents
- Clinical trial applications (CTAs) including Investigational Medicinal Product Dossiers (IMPD)
- CTD overviews and summaries
- Marketing authorisation application (MAA) dossiers
- Risk management plans (RMP)
- Periodic safety update reports (PSUR)
- Development safety update reports (DSUR)
- Paediatric investigation plans
- Orphan drug designation applications (ODD and OMPD)
- Responses to regulatory queries and product defence documents
Clinical trial documents
- Investigator brochures (IB)
- Protocols
- Serious Adverse Event (SAE) narratives
- Clinical trial reports
Strategic or development documents
- Clinical development plans
- State-of-the-art briefings on therapies or therapy areas
- Expert panel meeting reports and executive summaries
- Marketing support and training materials
- Critical assessments of papers
Publications
- Manuscripts for publication in the literature
- Marketing meeting reports and newsletters