Medical & Pharmaceutical
Precise translation and editing for regulatory compliance
Areas in which I regularly work:
- Manufacturing
- Market research
- Occupational health & safety
- Quality management
- Research & development
- Sales & marketing
Examples of texts and topics
with which I am familiar:
Medical
- Discharge summaries/medical reports
- Laboratory reports
- Brochures & websites
- Scientific articles
Clinical Research
- Study protocols & synopses
- Subject information/informed consent
- Case report forms
- Communication with
ethics committees/competent authorities - GCP inspections reports
- Study reports
Regulatory & Quality Management
- Benefit assessments
- CTD modules
- Communication with competent authorities
- GMP inspection reports
- Product information/brochures
- Marketing materials
- Package leaflets
- Product information/SmPCs
- Quality management handbooks
- SOPs
Seventeen years as an employee in the pharmaceutical sector have provided me not only with a sound knowledge of the industry, but also the appropriate insights and terminology for managing medical and pharmaceutical translations that will comply with the corresponding legal framework in such areas as GMP, GCP and regulatory affairs.
I deliver services to global players and SMEs, CROs, market research companies, and creative agencies – to name but a few.
I am familiar with the various requirements and standard terminology in areas such as GCP, GLP, GMP, QRD, and EDQM.