EMA Regulatory

I’ve been on the translation team for hundreds of European Medicines Agency Marketing Authorisation procedures, helping to make sure that leading pharmaceutical companies can bring their products to market in Europe.

My expertise with the procedure timelines, milestones, documentation and requirements means that I’ve given training webinars on the topic for fellow translators – and received great feedback!

“This was one of the best webinars I have attended – despite having worked in the field for over 10 years and been familiar with most of the facts, Nicole has organised every thing in a really comprehensive and well structured manner which helped me to make sense of the system (finally!).”

I follow the EMA updates and keep abreast of the latest QRD stylistic decisions and templates – so whether your procedure is centralised, decentralised or mutual recognition – you can rest assured it’s in safe hands.

SMPC

12,000+ words

PIL

12,000+ words

labelling

6,000+ words

MARKETING MATERIALS

10,000+ words