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“The regulatory directives apply to a market of nearly 560 million people in Europe.”
       
       
     
   
“US exports of pharmaceutical products to Western Europe increased by 304% from 1997 to 2004.” (OTEA)
       
       
     
   
“The US sold $16.5 billion in surgical and medical instruments to Western Europe in 2003.” (OTEA)

       
       
       
   
“ Imports of US medicines to Western Europe increased by 329%.” (OTEA)

Translation Services
 
 

MEDICAL TRANSLATION

Medical translation is unlike any other form of translation. It involves different levels of quality control, subject knowledge, types of documents to be translated, and regulatory control. Due to the importance and sensitivity of the documents, whether they are patient information sheets, toxicology reports, or packaging for a drug, utmost professionalism and thoroughness has to be applied. There is no room for confusion or error. Arranging for the translation of documents should begin as early as the pre trial phase of the product.

 

 

 

AbroadLink specializes in fulfilling the requirements of EU regulations for medical and pharmaceutical companies offering their products for sale in the EU. As our track record demonstrates we deliver documents to regulated industries on time and on budget. We work with companies manufacturing medical and in-vitro diagnostic devices as they prepare for compliance in Europe for CE marking. Our translation of product labels and IFU's meet EU Directive 98/79/EC for in-vitro devices and directive 93/42/EEC for general medical devices.

     
     
   

Pre Trial

Trial & Manufacturing

Post Trial

Patent & Associated Documents

Trial Report

Regulatory Audits

Clinical Trial Protocol

Manuals

Safety Records

Patient Information Sheets

Product Labels

Annual Repots

Informed Consent Forms

Packaging

Web Sites

Case Report Forms (CRF)

Insert Labels

Brochures

Patient Questionnaires

Dossiers

Pamphlets

Correspondence with IRB

Manufacturing Process Description

Public Information Campaign Material

Contracts

Pharmacological Studies

Direct Mail-Outs

Lab Reports

Instructions for Use

Newsletters

Serious Adverse Event Reports

Global Regulatory Filing Requirements

Graphic User Interfaces

Toxicology Reports

Training Materials

On-line Help Systems

             
   
       
   

AbroadLink has an experienced team of qualified professional translators, editors, and proofreaders with proficient language skills, excellent writing style, and above all else academic backgrounds in all key areas of the life sciences. Our medical translation process meets the precise needs of medical and pharmaceutical industries. Each stage is designed to deliver the highest quality possible. Click here to learn about our translation process.

The Advantages of choosing AbroadLink

Medical translation projects for international medicine and biotechnology go through our specially designed translation process. Benefits include:

  • Precise consistent translations achieved by the creation of a specialized glossary of terminology.
  • Accurate translations provided by a team of experienced expert translators and the use of up-to-date CAT tools.
  • Quality Assurance guaranteed from our specially designed translation process.
  • Better value due to volume discounts and, most importantly, discounts applied for repetition/similarities in texts.
  • Timely Delivery Guarantee
  • Transparency via 24 hour ftp access to monitor the project throughout its different stages.

 

Further reading about medical translation issues:
 
   
 
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