Sign In

Why Regulatory Teams Choose Sesen

Pharmaceutical regulatory teams turn to Sesen for specialized translation support that aligns with the highest standards of accuracy, compliance, and operational efficiency. Our team brings deep regulatory knowledge, linguistic precision, and scalable infrastructure to support every stage of the product lifecycle—from clinical development to post-approval labeling updates.

Sesen specializes exclusively in life sciences translation. Our team understands the scientific, regulatory, and linguistic precision required for pharmaceutical submissions and labeling in global markets.

We support end-to-end translation of CTD modules, INDs, NDAs, MAAs, variations, and health authority correspondence. Our linguists are trained in region-specific terminology and formatting standards to meet the requirements of EMA, FDA, PMDA, NMPA, and other global agencies.

Our ISO 17100, ISO 9001, and ISO 13485 certified processes ensure consistent quality, full traceability, and documented reviewer feedback for audit readiness and regulatory compliance.

We create and maintain multilingual termbases and client-approved style guides to ensure consistent use of medical and regulatory terms across all submissions and updates.

We deliver fast, high-volume translation across 100 languages using secure cloud infrastructure, multilingual DTP support, and a global team of regulatory linguists.

Sesen supports side-by-side quality assurance and in-context review of translated labeling and packaging content to catch layout or context errors before printing or submission.

Our experience includes projects for leading pharmaceutical companies across small molecule, biologics, and advanced therapy submissions. We translate documents critical to global approvals, renewals, and compliance inspections.

Our Regulatory Affairs Translation Services

Sesen offers specialized translation services tailored to the complex needs of regulatory affairs teams managing multilingual content across global markets. From initial health authority submissions to post-approval updates, our services ensure documentation accuracy, regulatory consistency, and linguistic precision across every stage of the product lifecycle.

Stepes provides accurate, regulator-approved translations of Summary of Product Characteristics (SmPC), Patient Information Leaflets (PIL), Instructions for Use (IFU), and all outer and inner packaging content. We follow the latest EMA QRD templates, FDA labeling standards, and country-specific requirements to ensure full compliance across global markets. Our DTP experts also support formatting and layout validation in all target languages.

We translate and format multilingual content for CTD Modules 1 through 5, including INDs, NDAs, MAAs, and post-approval variations. Stepes delivers submission-ready files that meet eCTD structure, regional language regulations, and submission formatting expectations across the EU, US, Japan, China, Brazil, and other regulatory regions.

Our linguists translate Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs and PBRERs), Development Safety Update Reports (DSURs), and related pharmacovigilance documents. All content is handled in accordance with local safety reporting timelines and health authority expectations to support drug safety compliance throughout the product lifecycle.

Stepes provides certified translations of official correspondence with regulatory bodies, including deficiency letters, briefing books, responses to health authority questions, and meeting documentation. We support proactive and timely communication strategies with EMA, FDA, PMDA, NMPA, and other national agencies.

We offer side-by-side review and in-context quality assurance of translated labeling materials, including multi-panel inserts, cartons, and folding box layouts. Our QA linguists check for linguistic accuracy, regulatory terminology consistency, and correct positioning to avoid costly revisions or print delays.

Countries and Languages We Support

Countries and Languages We Support

Stepes provides professional regulatory translation services in over 100 languages to support global pharmaceutical submissions, product labeling, and health authority communications. Our language solutions are tailored to meet local regulatory requirements and ensure compliance across regional agencies worldwide.

We support:

  • All official EU languages for EMA and national health authority submissions, including French, German, Spanish, Italian, Polish, Dutch, and more
  • Asian regulatory markets, including:
    • Simplified Chinese for NMPA submissions in mainland China
    • Traditional Chinese for Hong Kong and Taiwan
    • Japanese for PMDA documentation
    • Korean for MFDS filings
  • Latin American markets, including:
    • Brazilian Portuguese for ANVISA submissions
    • Latin American Spanish for countries such as Mexico, Argentina, Colombia, and Chile
  • Middle Eastern and CIS countries, including Arabic, Hebrew, Turkish, Russian, and Ukrainian, adapted to local pharmaceutical and legal frameworks

Our linguists are native professionals with regulatory translation experience and are trained in the specific terminologies used in Module 1 localization, labeling content, and region-specific safety and quality documentation.

Related Services

In addition to regulatory submissions and labeling, Stepes offers a full suite of translation services that support adjacent functions within global drug development and compliance. These related solutions ensure regulatory teams can manage multilingual content across clinical, safety, legal, and quality documentation with efficiency and confidence.

  • Accurate translation of SmPCs, PILs, IFUs, and packaging content to meet local regulatory requirements. We support multilingual labeling aligned with EMA QRD templates, FDA formatting guidelines, and region-specific health authority standards.
  • Certified translations of CTAs, site contracts, and study start-up documents to support global clinical operations and ensure legal clarity across investigator sites and regulatory bodies.
  • Translation of adverse event reports, PSURs, DSURs, and safety narratives to comply with pharmacovigilance reporting requirements in all target markets. Our services support both pre- and post-approval drug safety monitoring.
  • Professional translation of standard operating procedures, training manuals, and eLearning modules to support GMP, GCP, and regulatory compliance initiatives across multilingual teams.
  • Linguistic and formatting QA for translated labeling and packaging components using in-context review workflows. We ensure accuracy, consistency, and regulatory alignment before submission or production.

Linguistic and formatting QA for translated labeling and packaging components using in-context review workflows. We ensure accuracy, consistency, and regulatory alignment before submission or production.

Get Started with Sesen

Looking for reliable regulatory affairs translation services to support your global submissions, labeling, and health authority communication? Sesen delivers accurate, compliant translations in over 100 languages, backed by deep regulatory expertise and ISO-certified quality workflows. Let’s discuss how we can support your next submission or product update.

REQUEST A QUOTE REQUEST A QUOTE
BOOK A DISCOVERY CALL BOOK A DISCOVERY CALL