Drug Approval Translation

500 pages translated under pressing deadlines

In order to submit a new drug treatment for approval by the FDA, a leading biotechnology development firm needed over 500 pages worth of certified documentation translation services under pressing deadlines and strict regulations. By employing our stringent quality management system and leveraging a substantial translation memory database, LingArch ensured that the intricate formatting of the content was maintained and that the translations met all regulatory standards for quality. The project was completed ahead of schedule, and the company succeeded in obtaining FDA approval for the drug.

Services Rendered

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The Client

One of the world’s most well-known energy companies, providing its customers with fuel for transportation and energy for heat and light, as well as retail services and petrochemicals products for everyday use.

With operations in more than 100 countries, the company is run on the principles of strong corporate governance, a clear system of delegating accountability, and a commitment to integrity in all its business dealings. The client has nearly 100,000 employees globally and annual revenues of over $280 billion.

The Challenge

The client had invested millions of dollars into the development of drug. With FDA approval, their ground-breaking new drug could be made available to thousands of asthma sufferers across the United States; this, in turn, would generate millions of dollars in revenue that would fund additional research.

However, because client’s master batch records were written in French, the partners found themselves with over 500 pages of documentation that needed to be translated in order to submit the treatment to the FDA for approval. And due to the pharmaceutical industry’s stringent regulations that require superior translation services employing consistent, accurate terminology, the translation process promised to be complex.

The Solution

The client looked to LingArch to meet their language needs for the drug project. The company had developed a solid relationship with us over a number of previous high-value projects. As a result, we had a substantial translation memory database comprised largely of highly technical, regulatory-related terminology.

The linguists were able to refer to this database and leverage previously established client-approved terminology, ensuring consistency and accuracy throughout the 100,000 words that were translated from French into English. Additionally, through LingArch’s ISO 9001:2000 certified, three-step translation, editing, and proofreading process, intricate and critical formatting of the source material were reflected in the end product. This attention to detail proved critical, as submission to the FDA requires a rigorous and thorough representation of the original text.

LingArch delivered the translations ahead of schedule, giving the client ample time to prepare the documentation for submission to the FDA. In the end, drug achieved approval and has treated tens of thousands of patients in the United States.