Top-quality specialist translations by specialist native-language translators

The ideal formula: Specialist translations for the pharmaceutical industry

Translating pharmaceutical texts – it’s all about health

The pharmaceutical industry encompasses all drug manufacturers and suppliers. This spectrum includes drug research and new development of active agents and administration forms as well as drug manufacturing and marketing, whether generic or brand-name products are involved.
Pharmaceutical companies are subject to specific statutory regulations in drug law to ensure the quality, effectiveness, and safety of the drugs they manufacture and market. This includes preclinical and clinical trials as well as regular and case-specific monitoring for adverse effects in pharmacovigilance.
The actual translation requirements will vary according to the specific needs of the company and statutory regulations in the target markets. ConText® translators are highly qualified in every area.

Pharmaceutical translations – From approval process to package insert

Pharmaceutical product distribution is not usually limited to a particular national market, requiring translations in excellent quality for every target country. From development through approval to marketing, qualified specialist translators from the ConText® Pharma practice group have in-depth medical, pharmaceutical, and technical expertise enhanced by regular further training programmes organised by our translation agency.

Quality assurance over the counter

Experienced translation service providers such as ConText® have specialised language experts who comply strictly with specified standards; these include the Medical Dictionary for Regulatory Activities, abbreviated MedDRA, which is a compilation of standardised, mainly medical terms used in a wide variety of regulatory processes related to drug approval.

Research and development in the pharmaceutical industry

Pharmaceutical research is an international effort requiring information and data exchange between different countries. We translate research findings, study protocols, scientific articles, and patents, making it easier for scientists, researchers, and specialists from across the world to communicate.

Drug approvals

Having a drug approved in a particular country involves pharmaceutical companies submitting a variety of documents such as clinical studies, safety reports, specialist information, and patient information leaflets to the regulatory authorities of that country. A summary of drug characteristics (SPC) is a detailed document with information on the characteristics, dosage and administration, and contraindications of a drug. A package information leaflet or PIL provides all the information in the respective drug’s packaging. Apart from documents required for approval, we provide pharmaceutical companies with translations for a wide variety of regulatory documents such as quality management plans, standard operating procedures, and inspection and audit reports.

Training materials, online courses, and presentations

The pharmaceutical industry invests substantial amounts in staff training, especially in drug safety, GMP guidelines, and statutory regulations. We translate training materials, online courses, and presentations for pharmaceutical knowhow to be shared in a coherent and effective fashion.

Intellectual property

Brand development and intellectual property protection pose increasingly complex challenges for pharmaceutical companies. Applications need to be translated and submitted in the respective national language to secure patent protection in individual national legal systems. The pharmaceutical industry also generates a wide variety of scientific articles, research reports, manuals, training materials, marketing texts, and other copyrighted content. Copyright needs to be observed, possibly with consent from authors and/or copyright owners, when translating the content.

Licence Agreements

Pharmaceutical companies often conclude licence agreements with other companies to use these third-party technologies, patents, and medical products in other countries. ConText® translates licence agreements into all EU languages. Specialist translators in our Pharma practice group work closely with their colleagues in our Legal practice group when translating texts involving intellectual property.

Translations in clinical research and development

• Case report forms (CRFs) and CRF entries documenting anonymised patient data in clinical studies
• Declarations of consent
• Correspondence with authorities and ethics committees
• Reports on adverse events (AEs) and serious adverse events (SAEs)
• Monitoring reports
• Patient information and patient diaries
• Clinical trial protocols for phases I to IV
• Clinical trial synopses
• Study reports
• Drug product supply contracts with regulatory bodies such as the German statutory health insurance organisations, hospitals, and physicians registered with the public health system

Translations in pharmacovigilance

• Case reports
• Follow-up reports
• Direct healthcare professional communications (DHCPs)
• Serious undesirable effect (SUE) reports
• Yellow cards

Translations in drug approval

• Pre-licencing communications such as change notifications, public assessment reports (PARs), letters of objection, regulatory rejection letters
• Package information leaflets (PILs)/CMI leaflets
• Packaging texts and labels
• Certificates for pharmaceutical products
• Approvals for pharmaceutical products
• Summaries of product characteristics (SmPCs)

ConText® Pharma practice group

The ConText® Pharma practice group currently consists of eleven specialist translators with a focus on pharmaceuticals. We are familiar with the challenges facing companies in the health and pharmaceutical sector, and we translate texts in the fields of research, development, approval, and marketing. We are also happy to provide support in every language required for drug approval and in every phase of a clinical study from clinical outcome assessments (COAs) to specialist information valid throughout Europe, such as summaries of product characteristics (SmPCs).

Need a graduate native-language translator with thorough medical, pharmaceutical, and technical expertise? The ConText® translation agency is always by your side.