Regulatory Affairs in Pharma

From the discovery and testing to the manufacturing and marketing of your pharmaceutical products, globally and in any language, the regulatory landscape demands 100% accuracy, consistency and speed. 

That's where we come in.

Solutions for…

Submission Management

Global submissions require both extensive translation of regulatory documentation and strategic management of huge volumes of data—all done at speed and according to strict timelines. We ease the burden by serving as a partner in managing myriad requirements, translations, and deadlines.
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We help clients comply with regulatory requirements by managing the end-to-end preparation, translation, and submission of documents in adherence with regulatory references.
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Translation of Documents

We analyze and translate all types of key pharmaceutical documentation, including but by no means exhaustive, New Drug Applications (NDA) and Marketing Authorization Applications (MAA), annual reports, clinical/non-clinical study reports, chemistry, manufacturing and controls, summary tables, application forms, patient information labels, artwork and packaging, risk management plans, periodic safety update reports, correspondence and queries, and agency guidelines.
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