Pharma & Life Sciences

Pharmaceutical translation services and clinical trial documents

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

Specialised linguists for pharmaceutical content — 25 years of expertise

In 30 seconds

  • Methodology: Reduced risk of translation-related questions. Translations prepared according to intended use.
  • Turnaround: SmPC: 3–5 days. Patient Information Leaflets (PIL): 2–4 days. CTD Module: 2–4 weeks.
  • Terminology: MedDRA, ICH, WHO-DD coding. Controlled pharmaceutical terminology and validated glossaries.
  • Asia Expertise: Translation for Japanese, Chinese, and Korean markets. Specialised linguists.

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.

Sectoral Track Record

"A leading European pharmaceutical laboratory required a complete regulatory dossier (Modules 2, 3, and 5) translated into Japanese and Chinese grids. Result: Delivery achieved 10 days ahead of schedule. Controlled pharmaceutical terminology."

— Regulatory Director, Top 20 Global Pharma Company

📊 Case Study: Pharma MA — 10 days ahead of schedule, controlled terminology, Japanese + Chinese

Why laboratories trust us for pharmaceutical translation

  • Specialised linguists: Experts with background in pharmaceutical content and regulatory environments.
  • Multilingual Expertise: Deep experience with Asian (Japanese, Chinese, Korean) and European languages.
  • Controlled Terminology: Strict adherence to MedDRA, ICH, and WHO-DD. Use of glossaries and translation memories.
  • Quality Control: Human review and review workflow adapted to sensitive documentation.
  • Confidentiality: Confidential and secure handling of sensitive files.

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

Related services

Medical and Pharmaceutical Translation

Medical documents, clinical trials, and patient leaflets.

Sworn Translation

Official translations for administrative procedures.

Corporate Solutions

Dedicated project management and SLAs for large volumes.

Why regulatory affairs teams trust us

Reduced risk related to translation

Linguistic support for regulatory-context documentation.

Specialised linguists

Translation of pharmaceutical content with high precision.

Quality Documentation

Translation of procedures and pharmaceutical quality documentation.

Frequently Asked Questions

Which pharmaceutical documents do you translate?

We translate a wide range of documents: (1) Regulatory dossiers in CTD/eCTD format. (2) SmPC translation and patient leaflet translation. (3) Clinical study reports (CSRs) and clinical trial document translation. (4) Pharmacovigilance translation (PSURs/PBRERs). (5) Labelling and packaging. (6) Pharmaceutical quality documentation translation (SOPs, procedures). Our linguists are specialised in pharmaceutical content.

How do you ensure the quality of regulatory-context translations?

We implement a quality control adapted to the project: (1) Specialised linguists for pharmaceutical content, familiar with sectoral conventions. (2) Controlled pharmaceutical terminology (MedDRA, ICH, WHO-DD) and the use of glossaries and translation memories. (3) A cross-human review workflow. These measures ensure translations are prepared according to the intended use of the document.

What is your expertise in multilingual pharmaceutical translation for Asia?

This has been our historical specialty since 2000: (1) Japanese: translation of regulatory dossiers by specialised translators. (2) Chinese: Simplified and Traditional Mandarin for regulatory affairs. (3) Korean: specialised KR linguists. We adapt multilingual pharmaceutical translation to local expectations regarding terminology and drafting conventions.

What are your turnaround times and rates for pharmaceutical documents?

Pricing is calculated per word (€0.16–€0.22/word based on specialization). Examples: (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) Clinical study report: project-based quote (4-8 weeks). Accelerated delivery available. Custom quotes within 60 minutes (9 AM – 7 PM CET).

Need to translate pharmaceutical documents?

Entrust us with your sensitive content. Quote within 60 minutes (9 AM – 7 PM CET). Controlled pharmaceutical terminology and secure file handling.

+33 1 8425 7879

58 Av. de Wagram, 75017 Paris