Medilingua Products & Services

Pharmaceutical translation services


Pharmaceutical translation services


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Products & Services| MediLingua Medical Translations B.V.

Overview

MediLingua offers translation and content review services that are optimized for the pharmaceutical, biotechnology and life sciences industries.

The cost-effectiveness of these translation services is leveraged from deep expertise in the sciences and technologies involved, as well as the standards that need to be met. They are increased in scope by the wide range of European, Asian and African languages that MediLingua supports.

Rationale

As an ever-increasing proportion of drug development, clinical research and marketing is done multinationally, so the need increases for fast, accurate and cost-effective translation of pharmaceutical and other life sciences content into multiple languages.

This increasing need is apparent on many levels. To begin with drug development and manufacture, while two thirds of the value of medicines is concentrated in just five countries (USA, UK, Germany, France and Japan) the WHO assess that manufacturing capability is now spread over more than 125 countries that have pharma and biotech capabilities ranging from ‘sophisticated industry’ to ‘finished products from imported ingredients’.

Similarly the proportion of drugs marketed in the USA that are manufactured in Europe, Asia, Africa or Latin America has risen sharply over the past decade, from 20% to around 75% currently. India alone is estimated to supply 40% of the OTC medicines consumed in the US.

On the research front, clinical trials are becoming increasingly multinational, with an FDA study finding that the proportion of clinical oncology programs conducted exclusively in the USA declined from 80% in 2002 to around 25% by 2012.

The process of bringing a drug to market requires accurate translation at almost every stage, from pre-clinical research among collaborators, through multiregional regulatory submissions, dispersed manufacturing, and regional marketing and packaging.

Errors in translation can have drastic effects at key parts of the marketing process, including errors and delays in clinical trials, possible rebuffs or rejection by regulators, increased time to market and compromised product safety with potential legal or regulatory consequences.

Inadequate translation also has the potential to lose or obscure crucial data links between research sites operating in different languages. Corruption of essential data quality can make the difference between resounding success or very costly failure.

Compared with the costs involved, the marginal costs of high quality and industry specific translation are vanishingly small.

Capabilities

Pharma and biotech translation depends on precise and current knowledge of scientific meanings and technological terms on the part of every member of the translation chain from original drafting and editing in source language through to target languages.

MediLingua can provide these multilevel services for all European languages, as well as Turkish, Arabic, Hebrew, Chinese, Japanese and Korean. In Africa,MediLingua’s network of local partners, experienced in medical translations, provides coverage of many of the continent’s main languages and dialects.

Layered levels of quality control and full understanding of the regulatory environment are also required, extending to regulations on new drug development and marketing in North and South America, Europe, Asian and African markets.

MediLingua has built up a team of more than 400 professional medical translators, all of whom are native speakers of target languages with a medical background and extensive experience in translating and editing medical texts. They provide translators with access to the latest medical information and reference materials; with work double checked by expert editors to ensure that all translated information is clear and accurate.

MediLingua also provides complete review of translation against source documentation, using professional proofreaders and editors with specific medical and scientific knowledge, allowing the most qualified reviewer to be selected to meet each specific requirement.

Range of serivces

MediLingua is experienced in translating the full range of pharmaceutical and life sciences documentation including:

  • Case Report Forms (CRF)
  • Clinical Protocols
  • Informed Consent Forms
  • Data Sheets
  • Dossiers
  • Drug Registration Documentation
  • Manuals
  • Manufacturing Process Descriptions
  • Package Inserts and Labels
  • Patient Information Leaflets
  • Patient Questionnaires
  • Pharmacological Studies
  • Product Labels
  • Regulatory Documents
  • Scientific Papers
  • Toxicology Reports

Apart from proofreading, editing and Quality Assurance services, MediLingua provides page formatting (DTP) and pre-press services, along with terminology management and translation memory building databases.

Optionally, clients can specify pre-translation source text and post translation editing, management of in-country and third-party validations, compliant readability testing, linguistic consultancy and the back translations that are often required in clinical research.

Resources

Click on Pharmaceutical Translation Services for more information.
Click on MediLingua to contact the company directly.


Supplier Information
Supplier: MediLingua Medical Translations B.V.
Address: Poortgebouw – Rijnsburgerweg 10, 2333 AA Leiden, The Netherlands
Tel: +31 71 568 0862
Fax: +31 71 523 4660
Website: www.medilingua.com