We provide translations of documents relating to the research, development, registration and use of medicines in many languages including all EU languages:
- Summary of Product Characteristics (SmPC)
- Packaging texts
- Patient Information Leaflets (PIL)
- Marketing authorization
- Market introduction texts
Compliance is key
Our outstanding team of medical and pharmaceutical translators can draw on many years of experience and are wholly familiar with the requirements imposed by both national and European medical regulatory authorities. So you can be sure that the translation will comply with the latest QRD templates and MedDRA terminology.
Making the most of a tight time frame
During the registration procedure, there is usually very little time (only 5 calendar days after “Day 210”) between establishing the final English texts and submission of the various translations. This is why we prefer to start translating the provisional versions considerably earlier (around Day 185).
These translations can then be made in relative peace and the national offices of our clients will have the opportunity to check them carefully. Once the final English version has been established, the translations that have already been made can usually be adapted to this version within a few days and so be submitted before the deadline.
Registration holders are required to submit specific data to the European Medicines Agency (EMA) as part of the Identification of Medicinal Products (IDMP) project, in accordance with article 57.2 of EC Regulation 726/2004.
We know the applicable rules and regulations and can provide you with IDMP translations that meet all the requirements.
We can also test these documents for comprehensibility and readability.