Certified Specialized Translations
As a certified translation agency for pharmacy and pharmaceuticals, we know that the precise translation of your documentation is essential to overcome regulatory hurdles and secure product approvals. Approval dossiers, clinical study protocols, GMP documentation, and safety data sheets require both linguistic precision and in‐depth knowledge of international guidelines. Any deviation could pose risks to product safety and result in legal consequences.
Our specialized pharma translators and proofreaders are available in over 60 languages and work directly in the target country. With expertise in the requirements of the EMA, FDA, NMPA, and other international authorities, they ensure that your pharmaceutical documents are translated accurately and in compliance with regulations. Through collaborations with universities and research institutes, we guarantee consistent and compliant pharma translations.
Europe
EMA Approvals
MHRA Reports (UK)
ANSM Authorizations (FR)
Africa
SAHPRA Approvals (SA)
WHO Prequalification
NEPAD Inspections
Asia
PMDA Dossiers (Japan)
CFDA Applications (China)
CDSCO Documents (India)
Oceania
TGA Approvals (AU)
Medsafe Submissions (NZ)
Export Certificates (AU)
Americas
FDA Dossiers (USA)
ANVISA Reports (Brazil)
Health Canada GMP Audits
In pharmaceutical translations, understanding production processes and quality standards plays a decisive role. Our specialized translators focus on accurately translating detailed manufacturing instructions, stability studies, and process validations into the target language.
Precise Workflow Management
Our translation processes are designed to adapt optimally to your workflows. By implementing translation memory and terminology management systems, we reduce errors and boost efficiency in repeat projects, ensuring pharmaceutical translations that seamlessly integrate into your documentation and production processes.
Global Success through Precision
Pharmaceutical translations require not only excellent language skills but also continuous education in legal contexts. Whether it’s EMA approval applications for Europe, FDA approvals for North America, or NMPA documentation for the Chinese market – each region presents specific regulatory requirements that are constantly evolving. Our pharma translators specialize in the terminology and standards of these authorities, ensuring your documentation meets regional compliance.
Our service portfolio also includes translating stability reports in line with ICH guidelines for Asian and African markets, as well as adapting safety data sheets to meet Health Canada’s requirements. In multilingual markets like Canada or Switzerland, we ensure consistency with applicable regulations for package inserts and other mandatory information. The same applies to molecular validation reports, pharmacovigilance data, and production batch analyses.
In summary, our decades of experience enable us to translate complex scientific content quickly and accurately into the target languages, ensuring market approval deadlines are met – a decisive advantage that gives you the security and responsiveness needed in the global marketplace. We would be delighted to welcome you as our client!
Feedback
What Our Clients SayHello Ms. Müller, thank you for the excellent support! The collaboration ran smoothly, and the quality of the translations was top-notch. I look forward to future projects with you!
A. Hoffmann, JenaDear Dialecta team, many thanks for the swift execution of our project! Your flexibility and professionalism truly impressed us. The translations were perfect. Until next time!
M. Sauer, HamburgDear Ms. Krüger, we are truly grateful for your assistance! Everything went like clockwork; your prompt feedback helped us meet our tight deadlines. I will definitely recommend you!
L. Jaroslova, MunichTranslations in 60+ Languages
Are you looking for a translation agency for pharmacy and pharmaceutical production with extensive expertise in the field? Do you need pharmaceutical documentation translated into German, English, or French? Do you require a drug approval translation? Our pharmaceutical translation service offers excellent translators, whether for a large-scale project or minor technical translations.
Our translation agency for the pharmaceutical industry handles over 60 languages – including German, English, and French – as well as translators for Italian, Spanish, Dutch, Greek, Portuguese, Turkish, or Russian. In addition, our team features translators for Czech, Polish, Romanian, Slovak, Hungarian, Bulgarian, Croatian, Serbian, Albanian, and Ukrainian.
We are also active in the Scandinavian region, offering specialized translations in Swedish, Norwegian, Finnish, Danish, or Icelandic. Certified translators for Asian languages such as Japanese, Mandarin, Korean, Vietnamese, Thai, Arabic, Persian (Dari and Farsi), and Hebrew complete our offerings. For additional languages, please contact our translation management directly.
Our Services
