Pharmaceutical & Biotech Translation Services

Our pharmaceutical translations comply with FDA 21 CFR Parts 201, 312, and 11; ICH E6(R3) GCP; ICH M4 CTD format; EMA Clinical Trials Regulation (EU) 536/2014; PMDA submission requirements; and ISO 17100:2015 translation quality standards. Every project is documented with a full audit trail.

Yes. We provide full back-translation services with reconciliation reports for drug labels, informed consent forms, patient information leaflets, and other critical documents. Our back-translation process follows FDA and ICH guidance, with a qualified translator producing the back-translation independently from the forward translation, followed by a side-by-side reconciliation review.

We maintain 24/7 availability for urgent pharmacovigilance documents. SUSARs are typically turned around within 24 hours, with expedited options available for same-day delivery. We have dedicated pharmacovigilance linguist teams on standby for each major language pair, ensuring that safety signals reach regulatory authorities within required timelines.

Yes. We specialize in multi-market simultaneous submissions and have managed programs covering FDA, EMA, PMDA, Health Canada, TGA, and NMPA in parallel. We use centralized Translation Memory systems and terminology databases to ensure consistency across all modules and all target markets, with a single project manager coordinating the entire program.

We create and maintain client-specific Translation Memories (TMs) and approved terminology glossaries for each drug development program. All new translations leverage existing TM matches, and any new terms are flagged for client approval before being added to the glossary. This ensures that terminology remains consistent from the first IND filing through final NDA submission and post-market surveillance.

Yes. All pharmaceutical translators on our team hold advanced degrees in pharmacology, medicine, biochemistry, regulatory affairs, or a related discipline. We do not use general translators for pharmaceutical documents. Translators are also required to have a minimum of five years of pharmaceutical translation experience and undergo regular continuing education in regulatory affairs.

Yes. We provide certified translations with a Certificate of Translation for all regulatory submissions. The certificate attests to the accuracy and completeness of the translation and includes the translator's qualifications. Notarization and apostille services are also available for documents requiring official authentication.

All pharmaceutical projects are handled under strict confidentiality agreements, including mutual NDAs. We use encrypted file transfer (AES-256), role-based access controls, and secure project management platforms. Our information security practices are aligned with ISO 27001, and we execute Business Associate Agreements (BAAs) for HIPAA-covered information. All staff undergo annual data security training.