TMC Pharma Services has highly trained medical writers

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.

Medical writing

Regulatory documents
• Clinical trial applications (CTAs) including IMPDs
• CTD overviews and summaries
• Marketing authorisation application (MAA) dossiers
• Risk management plans
• Paediatric investigation plans
• Orphan drug designation (ODD) applications
• Responses to regulatory queries and product defence documents

Clinical trial documents
• Investigator brochures
• Protocols
• 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