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OUR SERVICES
Medical Writing and Translations
Our Medical Writers have diverse backgrounds in medical, pharmaceutical, and life sciences. They specialize in producing high-quality clinical documentation, adhering to ICH-GCP guidelines and local regulations. Communication is our priority, and our document preparation process involves experts from Biometrics, Regulatory, and Medical Affairs, ensuring accuracy and clarity. Rigorous quality assurance reviews are conducted before delivering the documents to our clients.
Medical Writing Projects we handle include:
- Clinical development plans
- New drug applications
- Clinical study reports
- Investigational Medicinal Product (IMP) dossiers
- Clinical study protocols and amendments according to ICH-GCP
- Subject information sheets and consent forms
- Investigator’s brochures
- Benefit/risk assessment reports
- Informed Consent Documents
- Annual clinical study reports
- Periodic Safety Update Reports (PSURs) and other pharmacovigilance documents
- Integrated Summaries of Safety and Efficacy (ISS/ISEs)
- Package inserts and patient information leaflets
- Summary of product characteristics
Our Translation team comprises native speakers experienced in translating all clinical study-related documents, including submissions to ethics committees/IRBs and health authorities, correspondence, protocol synopsis, protocols, subject information sheets, medical reports, abstracts, patient instructions, and other study-related documentation.
