Expand your Medical, Pharmaceutical, Biotechnology, Clinical Research, Clinical Trial company business to Brazil through Medical expert English to Portuguese translation services. Thaiane Assumpcao

Prescribing Information for Brazil, cancer treatment and market share strategy

Client: Pharma company

Services: Translation

Language pair: English into Portuguese

Volume: 20,000 words

Translation Memories and Quality Control technologies: SDL Studio and Xbench

I have been helping a multinational Pharmaceutical corporation submit to ANVISA the Full Prescribing Information of their medication for cancer for label expansion in the Brazilian market.

One of the world’s leading Clinical Research Organizations (CROs) — founded in Dublin, Ireland (1990) —, that provides consulting and outsourced development and commercialization services to Pharmaceutical, Biotechnology, Medical Devices and Government and Public Health organizations.

In collaboration, a UK-based multinational Pharmaceutical corporation that produces over 670 generic, specialty and branded pharmaceutical products for North America, MENA and Europe.

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The challenges

So that they could meet the legal regulation that governs prescribing information documents for the Brazilian market, the clients have the need to submit to the Brazilian National Health Surveillance Agency (ANVISA) amended and updated Full Prescribing Information documents (both for Healthcare professionals and patients), translated from English into Brazilian Portuguese language.

Those Prescribing Information documents are pertaining to the forthcoming launch of new doses of a solution medication for intravenous use indicated for breast cancer, non-small cell lung cancer, castration-resistant prostate cancer, gastric adenocarcinoma and squamous cell carcinoma of the head and neck.

The solution

Translation services provided according to ANVISA’s requirements and regulation.

The content
Full Prescribing Information for both Healthcare professionals and patients.

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Full Prescribing Information documents translated into Brazilian Portuguese, linguistically adapted according to the law and regulation authorities’ requirements and appropriate for the use of the medication in the Brazilian market.

Therewith, the Pharmaceutical corporation has been receiving assistance in their market share expansion strategy, being able to offer their products beyond the North America’s, MENA’s and Europe’s borders.

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