You already know that accuracy is crucial in medical and pharmaceutical translations. But the style and register must also fit cultural expectations.
All our medical and pharmaceutical translators and revisers work into their mother tongue. They have highly specialised medical and pharmaceutical knowledge and are constantly developing their expertise.
As required by our ISO certifications, you can expect each text to be rigorously checked by expert revisers. Our project managers monitor the entire process according to ISO 9001 and ISO 17100 standards.
EXCEPTIONAL QUALITY, ATTENTION TO DETAIL, PRECISION, AND STRICT CONFIDENTIALITY. OUR SERVICE IS TRUSTED BY CROS AND PHARMACEUTICAL AND MEDICAL COMPANIES.
We can translate your:
- PRODUCT INFORMATION—SUMMARY OF PRODUCT CHARACTERISTICS (SmPC), PACKAGE LEAFLET AND LABELLING
- PACKAGING INSERTS AND LABELS
- STANDARD OPERATING PROCEDURES (SOP)
- CLINICAL TRIALS – STUDY PROTOCOLS, INFORMED CONSENT FORMS (ICF)
- CASE REPORT FORMS (CRF)
- PATIENT RECRUITMENT MATERIALS
- PATIENT QUESTIONNAIRES
- CONTRACTS
- AGREEMENTS BETWEEN SPONSOR/CRO AND TRIAL CENTRE
- CLINICAL STUDY REPORT (CSR)
- PRECLINICAL AND CLINICAL EVALUATION REPORTS
- REGULATORY DOCUMENTS
- MANUFACTURING PROCESS DESCRIPTIONS
- MASTER BATCH RECORDS
- MATERIAL SAFETY DATA SHEETS
- REGULATORY DOSSIER /APPLICATION DOSSIER
- COMMON TECHNICAL DOCUMENT (CTD – eCTD) FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE
- MINISTERIAL APPROVALS
- EXPERT REPORTS
- MARKETING MATERIALS
- SCIENTIFIC ARTICLES
- INSTRUCTIONS FOR USE (IFU)
- INSTALLATION MANUALS FOR MEDICAL DEVICES
- TRAINING BOOKLETS
- MEDICAL REPORTS AND RECORDS
The advantages to you:
- Accuracy: not only are our translations linguistically correct, they also meet industry standards and comply with MedDRA terminology, EDQM Standard Terms and QRD templates, as well as the guidelines issued by the EMA, Italian Medicines Agency and other regulatory agencies.
- Trust and confidentiality: all our translators and revisers have signed non-disclosure agreements. This means you can expect your data and information to be treated with absolute confidentiality.
- Sworn and legalised translation: you can choose to have any translation sworn (certified) at the Courthouse. Or it can be legalised (with an Apostille).
- Certification of translation accuracy: you can request this certificate which attests that the translation is consistent with the original, was translated by a qualified mother tongue translator, and was revised by a second linguist. This gives you 100% guarantee of its quality.
