We offer a wide range of services that cover most of the Life Sciences companies translation and localization needs.
For example, we handle: Technical Documentation, Clinical research, Legal and regulatory, and Marketing, Website & Software.
Powerling translators have in-depth industry knowledge of safety, user documentation, and the entire life sciences commercial supply chain.
We also work with doctors and pharmacists who validate translations in some cases. They keep your documents highly confidential.
With our CAT (computer assisted translation) tool, Déja Vu, we can reduce translation cost by 30% and provide quicker turnarounds.
Déjà Vu also allows for seamless terminology management, creation of a translation memories and multilingual archival of all documents.
Our translators recognize that medical and pharmaceutical translations can involve a host of distinct categories, sub-categories, and lines of business. They have a thorough understanding of the terminology and writing style required in each case.
In addition to our translation teams, Powerling works with doctors and pharmacists who have signed confidentiality agreements on our clients’ behalf. Each professional possesses specialized knowledge as well as a full command of the languages involved to support and monitor our teams.
We can sign confidentiality agreementswith our clients upon request and offer our clients an FTP website as a secure place to share documents while fully preserving confidentiality. In addition, all the professionals involved in your project sign a confidentiality agreement and are bound by our general purchase conditions. They are liable for any disclosure of information.
We can also encrypt emails and files upon request.
There are three directives governing the sale of medical devices in the European Union (EU). These directives also determine the translation requirements for those products. Although there are many similarities among the translation requirements, it is important to note that EU members do not have the authority to determine separate requirements for medical devices.
The three directives are:
EU directives use the following scale to classify individual medical devices and accessories based on a device’s capacity to harm patients, users, and other people nearby,
Translation requirements can become increasingly complex according to their classification. The higher-risk devices in Classes II and III and most of those in Class I require certification by a third party and a representative registered with the EU.
Compliance with standards, package leaflets, communication packs and package leaflet updates 1,800,000 words in messages
Package leaflets, protocols, legal and sales agreements and financial reports 800,000 words into 2 languages
Package leaflets, compliance with standards, contracts and market authorizations 405,000 words into 5 languages
Test reports, package leaflets and compliance with standards 300,000 words into 8 languages
Sales agreements, leaflets & ingredients, expert reports, leaflets and packaging 800,000 words into 8 languages
Test reports, package leaflets, leaflet updates (further to the Reach directive of December 2006) 200,000 words into 8 languages
Compliance with standards, package leaflets and ingredients and websites 288,000 words into 6 languages
Protocols, market authorizations and development reports 280,000 words into 6 languages