The challenges
The client has an ongoing need to respond to Requests for Information (RFIs), including clinical information, storage conditions, dilution, mechanism of action (MoA), from authorities — such as the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA) and the Brazilian National Health Surveillance Agency (ANVISA) — and Healthcare and R&D organizations.
Those RFIs regard some of their Pharmaceuticals division products, including pertuzumab, crenezumab, obinutuzumab, tocilizumab, bevacizumab, alectinib, ocrelizumab and more.
In addition to the client’s need to communicate with other related organizations in Brazil, according to the Brazilian legislation, international documents need to be provided in Brazilian Portuguese for submission to ANVISA for consideration and label expansion.
The solution
Translation services.
The content
Letters, reports, forms, instructions, declarations and other documents responding to Requests for Information (RFIs).
