"Optimising the workflow not only offers great savings potential, but also the chance to improve quality and reduce processing times." Jessica Weigt, Team Leader Global Regulatory Affairs

The globalisation of markets has caused an enormous increase in the demand for language solutions. Outstanding language management and awareness of international regulations at mt-g ensure the faster development and marketing of products in the regulatory process.

Our Focal Points

The translation of product information (SmPC, PIL, labelling), while considering the relevant regulatory procedures and regulations of the individual European authorities. Clear definition of the translation project (pre- or post-opinion update or complete translation), adherence to the individual regulatory requirements (national, decentralised, centralised, or MR procedures), and QRD templates including annexes and EDQM standard terms, while being familiarised with the drug authorities involved in the regulatory process and understanding the meaning of the different steps (opinion day, national phase).

Our Spectrum

SmPCs, labelling, PILs (national, decentralised, MR and centralised marketing authorisation procedure), variations/line extensions/renewals, human and veterinary medicine: translation of product information according to EMA, Swissmedic, BfArM and EDQM specifications, as well as the creation of PDF documents according to the EMA User Guide and EMA Check List. Master batch records, validation and stability reports (according to GMP and GLP terminology), SOPs, PSURs, documentation of drug safety, pharmacological/toxicological reports, product monographs, correspondence relevant to the marketing authorisation process.