Pharmacovigilance translation at Ciklopea involves translating and interpreting a wide range of vital documents, such as adverse event reports, product labels, clinical trial documentation, and regulatory guidelines.
Our solutions are developed to deliver:
- Top quality
- Compliance with the target market’s regulatory standards
- Security and confidentiality
By accurately translating this information, healthcare professionals, regulatory authorities, and pharmaceutical companies can collaborate effectively, share knowledge, and take the appropriate steps to ensure drug safety.
All pharmacovigilance translations are performed by Ciklopea’s specialized professionals, who play a critical role in ensuring accurate and effective communication within the pharmaceutical industry. Our pharmacovigilance translators have a high level of proficiency in both the source and target languages. They also have the excellent grammar, vocabulary, and writing skills necessary to accurately translate complex medical and pharmacological terminology.
Additionally, our translators are familiar with drug classifications, adverse event reporting, clinical trial protocols, and the regulatory guidelines specific to pharmacovigilance. They are also knowledgeable with regards to the relevant regulatory bodies, such as the FDA (Food and Drug Administration) in the United States or the EMA (European Medicines Agency) in Europe.
We can help you with translating:
- Adverse event reports
- Patient case narratives
- Medical product labels and packaging inserts
- Clinical trial protocols and reports
- Investigator brochures
- Pharmacovigilance guidelines and regulations
- Drug safety summaries
- Safety data sheets (SDS)
- Standard operating procedures (SOPs)
- Patient information leaflets
