Regulatory Affairs in Pharma

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.

We help clients comply with regulatory requirements by managing the end-to-end preparation, translation, and submission of documents in adherence with regulatory references.

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.