Translation services for Regulatory Affairs departments

Do you need a translation service for the Regulatory Affairs department? If you are involved in the healthcare industry, you will be well aware of the pivotal role this department plays in getting these companies’ products to market. These businesses operate within tightly regulated domains throughout the entire production process, adhering to the prevailing legislation in each country.

The professionals in the Regulatory Affairs department are responsible for ensuring that all products intended for market release by the company comply with all regulatory requirements. Their involvement spans across every phase of product development, starting from the initial design and extending through to the distribution stage.

Part of their job is also to monitor any post-market changes, which could encompass the introduction of new ingredients, changes to labeling, and any innovative or transformative adjustments made to the product.

Beyond the healthcare industry, all companies operating within regulated domains have a dedicated Regulatory Affairs department:

  • pharmaceutical products;
  • agrochemical products;
  • medical devices;
  • cosmetic products;
  • dietary supplements;
  • energy;
  • banking;
  • Telecommunications.

    To do their job, Regulatory Affairs professionals must be familiar with the legislation in the different markets where they operate. They must also stay current with the latest updates and new requirements.


Translation service for Regulatory Affairs

In each market where a product falls under regulated activities, meeting specific requirements and regulations mandated by the authorities in each country is essential.

Consequently, a significant volume of documentation needs translation to facilitate the presentation and procurement of the requisite authorizations for commercialization.

The translation service for Regulatory Affairs is among the most specialized, requiring the expertise of highly specialized translators. Here are its key attributes:

  1. Native fluency in the language of the target country.
  2. Industry-specific training (pharmacy, chemistry, biology, banking, telecommunications, etc.).
  3. Understanding of the laws and regulations governing the product, along with adept management of source materials.
  4. Proficiency in the professional terminology and phraseology of the sector and in the presentation formats of each of the documents.
  5. Competence in the different registers in which the documentation is presented: technical, administrative, legal, advertising, economic, etc.
  6. Ongoing training keeping abreast of all protocols and legislations relevant to the product domain, encompassing both technical and linguistic aspects.
  7. Clear, concise and rigorous writing.

The document types managed by these translators include:

  • prospectuses;
  • technical data sheets;
  • texts for labeling and packaging;
  • patents;
  • legal and procedural content;
  • measurement tables, dosing guidelines, and volume/mass equivalences;
  • texts for product preparation and preservation;
  • internal reports;
  • balance sheets and income statements;
  • audits;
  • studies;
  • tenders;
  • professional guides and manuals.

A translation service tailored for Regulatory Affairs departments requires accuracy, expertise, and an unwavering commitment to confidentiality and privacy. At Linguaserve, we have specialized translators who work with the most advanced technological solutions to fulfill all mandated requirements.

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