Regulatory Submission Translation Services

Regulatory submission translation services support the multilingual content used to prepare, file, review, update, and maintain regulatory submissions for global markets. Depending on the program, this can include application documents, CTD/eCTD content, CMC documentation, clinical evidence, safety information, product information, labeling, health authority correspondence, amendments, and lifecycle updates. Sesen combines specialized life sciences translation with terminology governance, independent review, version control, formatting support, quality assurance, and centralized project management.

Sesen supports multilingual content for a wide range of regulatory applications and dossiers, including INDs, NDAs, BLAs, ANDAs, MAAs, CTAs, IMPDs, amendments, supplements, variations, renewals, and related supporting documentation. The specific language and document scope depends on the product, market, submission pathway, regulatory procedure, and stage of the product lifecycle.

Yes. Sesen supports multilingual content across CTD/eCTD Modules 1–5, including administrative and regional information, summaries and overviews, CMC and quality documentation, nonclinical content, clinical content, and supporting submission materials.

Sesen can align approved client glossaries, terminology databases, translation memories, previous submissions, existing translations, labeling, study references, and reviewer decisions before and during production. Controlled terminology is then applied across relevant documents and languages, while QA processes help identify potential inconsistencies in recurring terms and related content.

Yes. Regulatory documents often change while multilingual work is already underway. Sesen can manage revised source files, rolling releases, and subsequent updates through version-aware workflows designed to retain approved terminology, translated content, reference materials, and prior reviewer decisions wherever appropriate.

Yes. Sesen can incorporate client regulatory teams, medical and scientific reviewers, local affiliates, and in-country reviewers into structured review workflows. Approved feedback can be captured and applied consistently to related content so reviewer decisions continue to inform subsequent documents and updates.

Yes. Sesen can support multilingual health authority correspondence, requests for information, deficiency responses, clarification packages, amendments, updated submission content, and related regulatory communications. When Sesen has supported the original submission, existing terminology, translation memory, references, and approved reviewer decisions can help maintain continuity during subsequent authority interactions.

Yes. Sesen supports multilingual formatting and technical document preparation so translated content remains usable in the required document environment. More complex formatting requirements can be supported through Sesen's dedicated regulatory submission formatting service.

Sesen uses AI and automation selectively to support functions such as terminology analysis, content reuse, consistency checking, quality assurance, and workflow efficiency. For regulated content, AI does not replace professional linguistic judgment. Qualified life sciences linguists and reviewers remain responsible for contextual translation decisions, review, and final quality control.

Sesen combines submission-level project management with controlled terminology, translation memory, authoritative reference materials, version management, reviewer feedback, and cross-document quality checks. These controls help keep recurring terminology, numbers, units, references, study identifiers, and other shared content aligned as documents move through translation, review, revision, and delivery.

Yes. Depending on the scope and source readiness, Sesen can organize parallel language and document workstreams to support time-sensitive regulatory programs. Early planning is especially important because terminology preparation, reference alignment, reviewer availability, source-document changes, formatting, and QA can affect the critical path.

Sesen supports regulatory translation in 150+ languages, including major European, Asian, Latin American, Middle Eastern, Nordic, and Central and Eastern European languages. Language teams are aligned according to the target market, subject matter, content type, and project requirements.

Helpful inputs include the submission type and intended markets, target languages, document inventory, source files and expected updates, regulatory timeline, existing translations, approved terminology or glossaries, current labeling or product information, relevant previous submissions, internal or in-country review requirements, and formatting and delivery specifications. For complex submissions, Sesen can review the available materials with your team and help define an appropriate multilingual workflow before production begins.