Translate Regulatory Documents —
with Precision, Validation, and Patient Safety

Yes. PONS Translate features centralised terminology and glossary management that seamlessly adopts your MedDRA preferred terms (PTs), ICH-standard phrases, and company-specific International Nonproprietary Names (INNs) or proprietary substance names — and can be continuously extended. Once defined, all terms are automatically and consistently applied in every document, ensuring that MedDRA codes and regulatory standard texts are rendered identically across all language versions.

PONS Translate is hosted on EU servers in Germany, is fully GDPR-compliant, and never uses your data for external model training. Proprietary formulations, clinical study data, and regulatory submission documents never leave your data governance boundary. For organisations with the highest security requirements, we offer a complete on-premises installation on your own infrastructure — no data, including metadata, leaves your data centre. GxP-compliant validation documentation is available upon request.

PONS Translate can support the translation of regulatory documents for EMA Marketing Authorisation Applications (MAAs), national procedures (BfArM, ANSM, AIFA and others), FDA New Drug Applications (NDAs) and Biologics License Applications (BLAs), as well as submissions to MHRA and other international health authorities. The terminology and glossary management ensures that regulatory standard texts and MedDRA terms are translated consistently with the requirements of each respective authority. The quality assurance function automatically flags critical passages for review by your Regulatory Affairs team prior to submission.

PONS Translate applies AI-driven Quality Estimation, assigning a confidence score to every translated segment. Critical passages — posology and method of administration, contraindications, warnings and precautions, undesirable effects and adverse drug reactions (ADRs) — can undergo a second verification phase through AI-based post-editing. In addition, these critical sections should be reviewed by qualified human experts. This "six-eyes principle" — combining AI efficiency with human professional responsibility — represents the established best-practice approach for regulatory translations.

Specialised pharma translation agencies typically charge €0.30–0.55 per word — the highest rates in the translation market. PONS Translate is significantly more cost-effective depending on the number of users — for example, with 15 users and an average translation volume, the effective per-word cost is approximately €0.01–0.05. The Translation Memory further reduces costs for document updates and protocol amendments, as previously translated and approved passages are automatically reused.

Yes. PONS Translate provides a full REST API for integration into Regulatory Information Management Systems (RIMS), Document Management Systems (DMS), and submission platforms including eCTD publishing tools and submission gateways. Translation jobs can be initiated directly from within your existing regulatory workflow — with no manual export or import steps required. Integration with platforms such as Veeva Vault RIM and OpenText is supported via the API.