High-Precision Translation for FDA Submissions & Life Sciences

We use domain-trained neural engines specialized for life sciences, pharmaceuticals, and medical devices. Our platform incorporates terminology management to ensure consistency for terms in MedDRA and other glossaries. For critical documents like NDAs, BLAs, and 510(k)s, we offer an optional human-in-the-loop review by subject-matter experts to guarantee the highest level of accuracy and compliance.

Yes, we specialize in translating a full range of clinical trial documentation, including Informed Consent Forms (ICFs), clinical protocols, Patient-Reported Outcomes (PROs), and Investigator Brochures. Our translations ensure compliance with both FDA standards and the requirements of international Institutional Review Boards (IRBs) and Ethics Committees (ECs), facilitating multilingual patient recruitment and global trial operations.

Absolutely. Our AI leverages intelligent layout analysis to replicate the original formatting of your source document, including tables in clinical study reports, multi-column layouts in Instructions for Use (IFUs), and the specific structure of eCTD modules. This eliminates most manual rework. For perfect fidelity, our optional human typesetting service ensures the final document is publication-ready.

A certified translation for regulatory purposes requires a formal attestation of accuracy. Our process includes translation by a qualified linguist, followed by the issuance of a signed Certificate of Translation Accuracy. This certificate affirms that the translation is a true and accurate representation of the source document, meeting the standards required by the FDA and other global regulatory agencies.

We provide enterprise-grade security for all translations. Your data is protected with end-to-end encryption, both in transit and at rest. Our platform is compliant with major data privacy regulations and holds multiple security certifications, including ISO 27001 and SOC 2, ensuring your sensitive R&D data, intellectual property, and patient information remain confidential and secure.