Skrivanek

Translation Services for Pharmaceutical Packaging, Clinical Trials, and Regulatory Documentation

Translations life science industry

Skrivanek delivers language solutions to the life sciences industry, providing high-quality translations and product localisations throughout Europe, Asia, and the Americas.

The company has a department exclusively dedicated to life sciences and medical translations. Skrivanek's experts deliver high-quality translation services across the sector, including product packaging and information, clinical trials, research findings, medical device manuals, and marketing materials.

Working in more than 100 languages, Skrivanek's linguists, in-house native reviewers, project managers, software engineers, and desktop publishing (DTP) specialists utilise cutting-edge technologies to facilitate customer-driven solutions guaranteed by ISO 9001:2008 and EN 17100:2015 quality assurance certifications.

Having delivered outstanding language solutions for 22 years, Skrivanek's clientele includes global corporations such as Fortune 500 companies and the European Comission (EC).

Translation for drug packaging product information inserts

Skrivanek's high-quality translation services allow clients to adhere to global guidelines, communicating instructions and ingredients clearly to users of pharmaceuticals.

Its life sciences linguists are some of the best in their chosen fields and are all guided by the company's strict quality assurance and best practice policies. This focus on quality helps ensure all texts adhere to statutory, legal, and ethical requirements, delivering information to be featured on packaging, provided to participants of clinical trials, or research findings for medical device manuals and marketing materials.

Highly experienced, tested, and trained translators for medical products

To maintain its high standards of practice, Skrivanek ensures its translators are highly experienced, rigorously trained, and regularly monitored.

The company's minimum requirements include a university degree and at least two years' experience for a standard translator role and a related degree with at least five years' experience for a senior position. Previous experience and specialised knowledge from the life sciences sector is also required, alongside being a native speaker in the target language. These standards ensure all products are appropriately represented.

Accurate and safe translation methodology for pharmaceutical materials

Skrivanek works to ensure all information is accurate, as the company understands the importance of precision in the pharmaceutical sector. Specially designed methodology is put into practice, which is built on highly controlled workflows (including back translation), thorough and continuous education, linguistic support, and performance monitoring, using state-of-the-art word processing technology.

Skrivanek's translation management system (TMS) helps oversee multiple countries, languages, professionals, and documents into an efficient, unified process. Tracking workflow throughout a project, the system provides timeline information, terminology lists, and glossaries, while centralising a language translation memory (TM).

To ensure information remains confidential, Skrivanek's security procedures see that all access is restricted and protected with passwords on a secure server.

Regulation-compliant medical documents for clinical trials and drug or device development

Working closely with some of the world's most respected global companies and public health organisations focused on clinical trials, Skrivanek has established long-term relationships throughout the medical industry. All text produced is in compliance with a large number of regulatory requirements, including the European Medicines Agency (EMEA), the US Food and Frug Administration (FDA), structured product labelling (SPL), Medicines and Healthcare Products Regulations Agency (MHRA), and the Japanese Ministry of Health, Labour, and Welfare.

Skrivanek's experts are also experienced in translating clinical and regulatory documentation such as standards of practice (SOP), contracts, agreements, and case report forms.

Companies such as Novartis, Lilly Philips Medical Systems, Bayer, Biowet, AstraZeneca, and Pierre Fabre Pharma rely on Skrivanek's services.

Contact Details

Skrivanek Group
Na Dolinach 22
147 00 Prague
Czech Republic
+1 212 858 7561 (US)
+420 546 212 294 (Europe)
info@skrivanek.com
www.skrivanek.com