TRANSLATION AND PROFFREADING

We understand the regulatory context and 238 languages.

The Life Science Industry is an international business. Translations to local languages are often a requirement for working with products, customers and business partners outside the borders of Denmark. To get your message across, the translation of regulatory documents has to be both correct in use of language and fit the regulatory context. This will often lead to questions such as:

What does a comprehensive and thorough translation require? How do you ensure that a translation conveys both a respect for the language and authority requirements as well as a regulatory understanding? How fast can it be completed? What is the process?

AlfaNordic’s Translation- and Proofreading team (TP-team ) are well experienced in this area and understand the regulatory aspect of working in the life science-industry. We have a credible and proven record of translations in several languages, in due time and in a high quality – both in terms of language and the regulatory aspect. We also offer a special overview of documents to ensure regulatory compliance is achieved. International cooperations open for new possibilities. To catch them, requires specialists with a regulatory understanding and a big knowledge of the language. Get ready to reach your goals with the help of AlfaNordic.

QUICK, HIGH QUALITY TRANSLATION

One week is set as our standard duration for tasks of translations, no matter the language. However, it is possible to get a task done in less than 5 days.

Regulatoriske dokumenter er vigtige at have styr på, lige meget hvor i verden man ønsker at sælge sine produkter.  Vi oversætter alt fra indlægssedler, produktresuméer, hjemmesidetekster og leverandøraftaler.

We do both single translation tasks and assist you during a translation task according to the needs of your company.

Translations of high quality are important for us. Therefore, we attribute to a great value in personal assistance and service in the task, which includes a quality check and proofreading.

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CONFIDENTIALITY IN THE COOPERATION

Knowledge and trust are our key-values.

With our key values in mind, we are willing to talk about ourselves – our knowledge of the industry and competencies – but not about our customers.

All communication with companies will therefore take place in a confidential environment. We appreciate remaining confidential, from the initial phases of the collaboration, we will form a confidentiality agreement. 

By doing this, we can ensure that companies feel safe in letting us translate and look through important regulatory documents. All communications between customer and consultant is confidential.

PROOF AND REGULATORY RUN-THROUGH

The Life Science Industry is under regulations, and several companies’ experience challenges in translating paragraphs into practice. An example could be the content of marketing material: It can be difficult to evaluate when a formulation of a product is limited by the rules of claims.

AlfaNordic’s specialists have expertise in the rules in force and experience in going through a variety of document types, also within the content of marketing material. We identify formulations as regulatory inexpedient and advice you on how to avoid these “grey zone areas of formulations”. In that way, we help companies comply with the regulatory requirements.

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OUR EXPERTISE WITHIN TRANSLATIONS AND PROOFING

Below are examples on types of tasks that we have solved

TASK OF TRANSLATION

  • QRD: Summary of Product Characteristics, Package leaflets and labelling.
  • Supplementary Protection Certificate.
  • Lists of products.
  • Reports.
  • Contracts and agreements with suppliers, business partners and customers.

PROFFREADING & REVIEW

  • Review of content for marketing material and advising of changes of inexpedient formulations.
  • Overview of current rules for marketing material of different kinds of products.
  • Run-through of product descriptions, texts for webpages, material for packages and labels.
  • Proofreading of brochures, presentations, and similar sales content for fairs and conferences.

APPLICATIONS

  • Review of dossier and feedback on application materials before submission
  • Changes of existing content and/or composition of new documents.
  • Advice on the application procedure, submission, and follow-up dialogues with relevant authorities
  • Assistance for related activities, as an example an inspection of authorities.

WANT TO KNOW MORE?

Let us set up a meeting to discuss the possibilities for your company. 

CONTACT US FOR TRANSLATIONS AND PROOFREADING

Get the message out, with the assistance of AlfaNordic

Else Nedahl

Translation- and proofreading team

Subject areas
Translation
Proofreading
Regulatory Affairs

+45 41 39 72 39
EN@alfanordic.com

Ole Markersen

Vice President 

Subject areas
Medical Device
Cosmetics
RA, QA and safety 

+45 31 44 75 11
OLM@alfanordic.com

Lisbeth Bonde

Sales and Marketing Manager

Subject areas
Customer contact
Propositions and contracts
Follow-ups

+45 31 44 75 44
LIBO@alfanordic.com

LET'S GET STARTED

BOOK A CONSULTATION, FREE OF CHARGE 

Are you ready for changes? Let us talk about your company’s ambitions and how we can break through in a new country.

Get an idea of what we can offer, by participating in our inspiration meetings. Here our specialists share their knowledge and experiences.

MEET OUR SPECIALISTS - PARTICIPATE IN OUR INSPIRATIONAL MEETINGS

CONTACT US

Do you have any questions, or do you want to know more? Contact us. You can find our contact information below. We look forward to hearing from you.

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