Pharma & Life Sciences

Pharmaceutical and regulatory translation services

Marketing authorisations (MA) | SmPCs & PILs | Pharmacovigilance | Clinical trials | Labelling

Native pharmacist-translators — 25 years of expertise — Asia specialists

En 30 secondes

  • Regulatory Guarantee: Zero translation-related regulatory queries. Full compliance with EMA, FDA, PMDA, and NMPA guidelines.
  • Turnaround: SmPC: 3–5 days. Patient Information Leaflets (PIL): 2–4 days. CTD Module: 2–4 weeks.
  • Terminology: MedDRA, ICH, WHO-DD coding. Glossaries systematically validated by your Regulatory Affairs (RA) team.
  • Asia Expertise: PMDA (Japan), NMPA (China), MFDS (Korea) submissions. Specialized native pharmacist-translators.

Pharmaceutical translation: Where precision impacts public health and market access

In the pharmaceutical sector, a translation error can delay a marketing authorisation (MA) by several months, trigger an agency query, or compromise patient safety. Scientific translation requires a triad of expertise: linguistics, scientific knowledge, and regulatory affairs.

Since 2000, Asiatis has partnered with European laboratories, CROs, and biotech firms. Our historical specialization lies in Asian languages (Japanese PMDA, Chinese NMPA, Korean MFDS) — managing submissions in some of the most stringent regulatory environments worldwide.

Core regulatory documentation

MA Dossiers (CTD/eCTD)

Modules 1-5 in CTD format. Submissions for EMA, FDA, PMDA, NMPA. Specialized scientific translators assigned by module.

SmPCs & PILs

Summary of Product Characteristics and Patient Information Leaflets conforming to European QRD templates and stylistic guidelines.

Clinical Studies (CSR)

Clinical study reports, protocols, informed consent forms (ICF), and CRFs adhering strictly to ICH E6/E9 formatting.

Pharmacovigilance

PSURs, PBRERs, CIOMS, MedWatch. MedDRA terminology mapping. Safety reports delivered within strict mandatory deadlines.

Regulatory Track Record

"A leading European pharmaceutical laboratory required a complete MA dossier (Modules 2, 3, and 5) translated into Japanese (PMDA) and Chinese (NMPA) grids. Result: Submission accepted without query, achieving the regulatory timeline 10 days ahead of schedule. Fully compliant."

— Regulatory Director, Top 20 Global Pharma Company

📊 Case Study: Pharma MA — 10 days ahead of schedule, 100% compliant, Japanese + Chinese

Why laboratories trust us for regulatory translation

  • Pharmacist-translators: Dual background in pharmaceutical sciences and local market regulations.
  • Asia Specialists: Deep experience with PMDA, NMPA, and MFDS operational frameworks.
  • Standardised Terminology: Strict adherence to MedDRA, ICH, and WHO-DD. Pre-validation of glossaries with your RA department.
  • 25 years of operation: Paris-based since 2000. Offices in Canada and Singapore. Support for 150+ languages.
  • Responsiveness: Quotes within 60 minutes (9 AM – 7 PM CET). Urgent processing available for pharmacovigilance or RFI needs.

See also our medical translation solutions and SaaS & IT expertise.

Related services

Medical Translation

Medical device manuals and clinical literature.

Certified Translation

Sworn translations for legal and regulatory authorities.

Corporate Solutions

Dedicated project management and SLAs.

Why regulatory affairs teams trust us

Zero queries

Translations fully compliant with EMA/FDA/PMDA.

Native pharmacists

JP, CN, KR specialists. Operating from Paris since 2000.

GMP/GLP compliant

Full traceability and QMS adherence.

Frequently Asked Questions

Which pharmaceutical documents do you translate?

We cover the complete regulatory lifecycle: (1) MA dossiers — CTD/eCTD format (Modules 1-5). (2) SmPCs and patient information leaflets (PILs). (3) Clinical study reports (CSRs) and protocols. (4) PSURs/PBRERs for pharmacovigilance. (5) Labelling and packaging. (6) Quality assurance documentation (GMP/GLP). Our teams consist solely of pharmacists or biologists specializing by therapeutic area.

How do you guarantee EMA, FDA, or PMDA compliance?

We deploy a three-tier security model: (1) Certified pharmaceutical translators trained in localized regulatory requirements (EMA, FDA, PMDA, NMPA, MFDS). (2) Standardised terminology via MedDRA, ICH, and WHO-DD, alongside glossary validation by your RA team. (3) Dedicated QA: review by a second specialized translator plus a final check by a pharmacist. This delivers translation outcomes with zero regulatory queries.

What is your capability in Asian languages for the pharmaceutical sector?

Translating into Asian languages has been our core competency since 2000. We offer: (1) Japanese: PMDA and J-CTD dossiers handled by native Japanese pharmacists. (2) Chinese: NMPA/CDE submissions in Simplified and Traditional Mandarin. (3) Korean: MFDS dossiers via specialized KR regulatory translators. We navigate local requirements that deviate significantly from EMA/FDA parameters, including precise submission formatting, official phrasing, and structural conventions.

What are your turnaround times and rates?

Pricing is calculated per word (typically €0.16–€0.22/word based on specialization). Typical ranges: (1) 10-page SmPC (~5,000 words): ~€800–€1,100 (3-5 days). (2) PIL: ~€400–€700 (2-4 days). (3) CTD Module 2: custom quote (2-4 weeks). (4) Full CSR: project-based quote (4-8 weeks). Accelerated delivery applies subject to a 30-50% surcharge. Custom quotes are delivered within 60 minutes (9 AM – 7 PM CET).

Need to translate a pharmaceutical regulatory dossier?

Submit your documentation below. Quote within 60 minutes (9 AM – 7 PM CET). Full EMA/FDA/PMDA compliance.

+33 1 8425 7879

58 Av. de Wagram, 75017 Paris