Pharmaceutical Texts and Package Inserts – Expert Translations for Safety, Trust, and International Compliance
In the pharmaceutical industry, linguistic precision and regulatory compliance are non-negotiable. Whether it’s drug information, product leaflets, or registration documents: accurate, legally sound translations are essential — not only for entering international markets, but also for protecting patient safety.
Bohemian Dragomans® is your certified partner for pharmaceutical translations — delivering proven quality, subject-matter expertise, and meticulous execution across all content types.
What Makes Pharmaceutical Translations So Demanding
Pharmaceutical texts are governed by strict regulatory frameworks — such as those of the EMA, FDA, or WHO. Translations must mirror the original content exactly — in meaning, terminology, and structure. At the same time, they must remain clear and accessible to both professionals and end users.
Typical documents we translate for our pharmaceutical clients include:
- Clinical trial documentation (protocols, consent forms)
- Drug registration dossiers
- Labels, packaging content, and safety information
- Marketing materials and field force communications
- Package inserts (PILs)
- Product monographs and regulatory submissions
- Risk management plans and pharmacovigilance reports
- Summaries of Product Characteristics (SmPCs)
Our Expertise: Pharmacological Accuracy Meets Linguistic Precision
Our pharmaceutical translators are highly qualified professionals with backgrounds in medicine, pharmacy, or life sciences. They’re well-versed in industry-specific terminology and know how to fine-tune language to suit the target audience, document type, and regulatory context.
We use customized terminology databases, translation memories, and QA tools to ensure consistency and legal security — particularly in multilingual approval processes and pan-European product launches.
Certified Processes – For Drug Safety and Regulatory Compliance
Bohemian Dragomans® is certified to the international standard DIN EN ISO 17100, the benchmark for professional translation services. We also align with DIN EN ISO 9001, and often exceed required standards with internal processes such as our six-eye review principle for highly sensitive content.
Data protection is equally integral to our work: we guarantee GDPR-compliant handling, secure internal systems, and tightly controlled access rights — ensuring the highest level of security for clinical and regulatory documents.
Your Benefits with Bohemian Dragomans®
- Subject-matter translators with pharmaceutical backgrounds
- Certified quality assurance in line with DIN EN ISO 17100
- Consistent terminology through curated glossaries and TMs
- Reliable review processes (four- or six-eye principle)
- High-level data protection for sensitive health information
- Scalable, project-specific quality management