Drug registration, medical device certification, pharmacovigilance, and documentation translation.
Complete dossier preparation for registration with Russian and EAEU regulators. Original and generic drugs. Full CTD/eCTD documentation packages.
Regulatory dossier preparation. Technical and clinical testing. Certification and declaration of conformity.
Safety monitoring system setup. PSUR/PBRER, adverse event registry, personnel training.
Specialized medical translation: protocols, instructions, dossiers. SDL Trados, notarized certification.