MHRA vs EMA Labelling Requirements – What Are the Key Differences?
Since Brexit, the UK drug market has undergone dramatic shifts. In order to be compliant, manufacturers now have to deal with two sets of rules: EMA and MHRA. Both have high standards for drug safety, but operate differently and have different labelling requirements....
Back Translation in Clinical Trials: When Is It Required and How Does It Work?
Back translation in clinical trials is an additional quality‑assurance step that helps to ensure that the translated content conveys the same meaning, safety implications, and regulatory intent as the original. This is especially essential in high‑risk, patient‑facing...
EMA QRD Template: Compliance Guide for SmPC and PIL Submissions
If you work in pharmaceutical regulatory affairs or translation, you have almost certainly encountered the EMA QRD template. According to the European Medicines Agency, human medicines are currently authorised through the EU centralised procedure alone, each requiring...
What is The Importance of Medical Translation for Hospitals and Clinics?
In the United Kingdom’s increasingly multicultural society, clear and accurate communication is the cornerstone of adequate healthcare. With over 300 languages spoken in London alone, the ability to bridge linguistic divides is not just an advantage but a...• Officially Certified & Recognised
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