The life science sector is an international industry, and consequently it is often a requirement for companies to make translations to local languages when working with products, clients, and partners outside the home market. In order to get the message across, the translation of regulatory documents must be both linguistically correct and fulfil the regulatory context.
The question often arises: what is required to get a quality translation? How do you ensure that a translation takes both linguistic nuances and regulatory requirements into consideration? How fast can it be done? How does the process unfold?
Our translation and proofreading team understands the regulatory conditions of the life science industry and it has many years of experience translating text for the industry. With just a few days’ notice, we are capable of making high quality translations regarding both linguistic and regulatory content to and from the world’s main languages.
We also a separate detailed review of documents to ensure regulatory compliance. International cooperation opens up for new opportunities. To seize them requires specialists with a regulatory understanding and linguistic pre-eminence.
Fast translations in high quality
Our delivery time for translation is normally one week, no matter which of the world’ main languages you choose. If the translation is urgent, we can also deliver it faster.
No matter where in the world you wish to sell your products, it is crucial to have a full dominion of regulatory documents. We translate everything including package leaflets; summaries of product characteristics; texts for webpages; and supply contracts.
We provide both single translations as well as ongoing linguistic assistance to translations, depending on the individual needs of each company.
The quality of the translations is crucial to us. Consequently, we emphasize the personal service when solving the tasks which always include quality check and proofreading before we deliver the translation.
Professionalism and trust form the foundation of our work. Therefore we are prepared to talk about ourselves and our professional competences, but not about our clients.
Our dialogue with our clients takes place in a confidential environment, and it is important for us to make clear from the start that we normally sign confidentiality clauses in the early stages of the dialogue on cooperation.
In this manner, we make sure that the company can safely let us translate and revise important regulatory documents. The information we receive stays safe within NIRAS.
Proofreading and regulatory revision
The life science industry is highly regulated. Many companies face challenges when they have to turn the regulations into action, for instance when it comes to marketing materials.
It can be difficult to assess when the wording about a product is on bordering on the rules regarding claims.
Our specialists have expertise in the relevant rules, and they have experience in reviewing many different types of documents, including marketing materials.
When we revise texts, we identify phrasing in texts that are regulatory inappropriate, and we advise on how to avoid unclear wording.
In this manner, we help companies to communicate a message within the framework of the regulatory requirements.
NIRAS’ expertise in translation and proofreading
Below are examples of types of tasks we have solved:
- QRD: product summaries, package leaflets and labeling
- Supplementary Protection Certificate
- Product lists
- Contracts and agreements with suppliers, partners and customers
Proofreading and review
- Review of marketing material and advice on changing any inappropriate wording
- Overview of current rules regarding marketing different product types
- Review of product descriptions, website texts, packaging material and labels
- Proofreading of brochures, presentations, sales material for trade fairs and conferences, etc.
- Reviewing files and feedback on application materials before submission
- Modification of existing materials and / or preparation of new documents
- Advice on application procedures, submitting proposals and follow-up dialogue with relevant authorities
- Help with related activities, e.g. authority inspection