We translate documents for all modules of the registration dossier, including documents on the quality of medicinal products and substances, validation documents (pharmacopoeial monographs, methodologies, stability studies, certificates of analysis, justification of specification(s), safety data sheets, characterization of impurities), documents on manufacturing processes and manufacturing sites, GMP inspection reports, reports on clinical trials and preclinical studies, documentation and reports on pharmacovigilance, and many other documents.
Each year, we process approximately 150,000 pages of pharmaceutical and regulatory documents. To check the quality of pharmaceutical translations, we engage the experts in the areas of registration, manufacturing, and quality assessment of medicinal products.