Professional consecutive interpretation during GMP inspections and audits in the pharmaceutical plants in order to verify compliance with good manufacturing practice (GMP), carried out by the regulatory authorities of the Russian Federation, Kazakhstan and Belarus.
Translation of pharmaceutical documents: Registration Dossier, Marketing Authorisation Application, DMF, drug safety profile, regulatory documentation, leaflets, CAPA documents, inspection reports, Site Master File, etc.
Translation and linguistic support during the preparation for GMP inspections, for example: completing the application and the required forms for inspection, translating the inspection plan and documents to be considered during the inspection, helping to solve organizational problems and ensuring communication on all business and additional issues at the preparation stage and during the inspection.