PROFESSIONAL REGULATORY AFFAIRS TRANSLATION SERVICES
Meeting international regulatory standards is critically essential for medical device manufacturers, pharmaceutical companies, and CRO firms to tap into global markets. The international regulatory bodies have stringent rules and regulations that are unlikely to be met without assistance from regulatory compliance translation. That’s where WordsLinker can help.
The target of a regulatory translation company is to fall on the standards of cost-saving translations coupled with the regulatory standards of the target locale. This, in return, helps the company to achieve the expectations of the market in order to be successful. To gain approval for the medical products produced by a medical company, its regulatory translation, construction, and strategies of the translation business play a very significant role. WordsLinker has gained popularity in the field of medical sciences through high-end certified regulatory translation services.
WHY YOU NEED REGULATORY COMPLIANCE SERVICES
There’s no room for errors in regulatory submissions. If there are any errors made, it could massively lead to a loss of customer trust and could have fatal consequences. Hence, every regulatory documents translation has to be precise, falling upon the ideal standards of regulations. Therefore, choosing an unprofessional or uneducated native speaker for your regulatory materials translation is not a sensible decision.
Language translation for regulatory affairs is a highly specialized and complex field that requires accurate and precise translation at each level of your business. Therefore, it’s recommended to take professional assistance in this regard. Looking for reliable regulatory compliance translation services? WordsLinker is your go-to option!
ALL-IN-ONE TRANSLATION SOLUTION FOR REGULATORY DOCUMENTS
Our regulatory translation services determine the value of your products so that they can gain their respective recognition in the marketplace. An extensive range of regulations deters the process for most pharmaceuticals. However, at the WordsLinker, you don’t have to face these problems because we make sure to cover these for you as we work with the top-tier translation experts of the medical industry in order to ensure that the end result is effective regulatory translate solutions. We ensure to provide you with the best compliance translation services in the respective areas:
- Instructions for Use
- Package Forms
- Drug Product Information
- Compliance translate
- Standard Operating Procedures
- Documentation
- Chemistry, Manufacturing, and Control Documentation
- Regulatory Dossiers Packaging
- Patient Prescribing Information
- Labeling Common Technical Documents
- Summary of Product Characteristics
- Regulatory Correspondence
FAST AND ACCURATE GLOBAL REGULATORY SUBMISSIONS TRANSLATIONS
WordsLinker provides you with first-rate regulatory translations so you can submit your documents with confidence to health authorities around the world and get your business approved successfully.
If you want to take your medical devices or pharmaceuticals to different countries, we provide the best translation solutions that meet international regulatory standards.
REGULATORY TRANSLATION FOR NMPA
If you want to expand your business to China, you will need to translate your documents from English or other languages to Chinese to meet the standards of the Chinese regulatory body NMPA or National Medical Products Administration.
Don’t worry you can always rely on us when it comes to professional regulatory submission translation for NMPA.
REGULATORY TRANSLATION FOR EMA
Our regulatory submission translation services can also help you make a successful entry into European Union. Experts in all 24 languages of the European Union, we would make your journey for approval of EMA (The European Medicines Agency) easy and quick.
You can request our regulatory translation services for EMA to translate such documents as product information leaflets, labels, product characteristics, and more.
REGULATORY TRANSLATION FOR PMDA
WordsLinker has also become a leading choice for drug companies looking to launch in Japan. This is especially due to our in-depth experience in regulatory translation for PMDA, the regulatory agency in Japan, known as Pharmaceuticals and Medical Devices Agency (PMDA). If you require PMDA approval for medical devices, we will assist you in translating medical device manuals, software apps, training guides, and more. Similarly, if you’re aiming to achieve regulatory compliance for pharmaceutical products, our native Japanese linguists would help you translate all documents like:
- Drug inserts
- PROs (patient-reported outcomes)
- COAs (clinical outcome assessments)
- Medical patents
- Packaging labels, and much more.
CERTIFIED REGULATORY TRANSLATIONS BY TOP-RATED EXPERTS
For the last few years, we have successfully raised a standard in the market by providing customers with top-tier medical regulatory documents translation. To achieve this successful position today, we have worked effortlessly. Our experienced team of translators provides precise and accurate translations of your regulatory compliance documents. These workers, having experience worthy of many years, are not only translators but experts in the regulatory language.
At WordsLinker, we have experts in language, regulation, and interpretation with massive experience to fulfill your compliance translation needs. All these elements will help you become successful in global markets through our professionals, who are experts in every domain of medical sciences.
Our broad network of 15000+ translators have:
- Training and certification
- Language expertise
- Ability to deliver fast and accurate results
COMPLIANCE WITH REGIONAL REGULATIONS FOR GLOBAL REACH
To expand your products to new markets, you need to break the language barrier and ensure complete compliance with regional regulations. This cannot be done without professional help and that’s exactly what we are here for!
The experts and professionals working at the WordsLinker effectively meet the client’s standards and help them reach the international markets by meeting all the regulations. Moreover, our team of experts thoroughly responds to any changes in the regulatory system. They dignify your work linguistically but also ensure that the target of the international ground you are trying to reach is successful by providing you with top-notch regulatory affairs translation services.
HOW WordsLinker IS THE BEST REGULATORY TRANSLATION AGENCY
In order to meet the standards of the global marketplace, our translators have been working to reach the precision of the translation without any compromise on the quality. The areas that we cover include:
- Biotechnology
- Pharmaceutical industry
- Medical care
- Medical devices and much more.
Our team of professional translators is strictly dedicated to their regulatory translation services and makes sure to provide the best to our clients in terms of quality and service.
- Subject Matter Expertise
- Advanced Background Knowledge
- Experience (in PMDA, CFDA, FDA, etc)
- Fast Turnaround
Ready to Tap into Foreign Markets?
What Is Regulatory Translation?
Certain documents require approval for implementation and communication. These documents, called regulatory documents, are an integral part of the medical industry. The regulatory translation is the translation of documents related to the approval and compliance of medical devices, pharmaceuticals, and medical diagnosis products. Many countries, such as the USA and Japan, require that the dossiers and approval files for new medical products be translated and submitted in multiple languages in order for regulatory bodies to read and analyze them. Moreover, the regulatory translation of complex documents enables these authorities to approve and implement medical rules and regulations for global medical diagnosis and treatments.
What Is the Process for Regulatory Translation?
The process for regulatory translation is a long one. This process starts with the collection of appropriate data from sources and the editing of this information to achieve the desired tone. After the regulatory translators have dealt with the translation of regulatory files, the text may have to undergo various levels of publication before being presented in the local language of the regulators. It must be kept in mind that the translation of regulatory documents requires fact-checking and proofreading before being sent for approval, as any error in translation can have detrimental consequences for the medical community. This fact-checking and re-assessment is not just to ensure there is clarity in the documentation, but also to create an appeal for the regulators for a better chance of a positive outcome.
How Do You Ensure the Correctness Regulatory Translation?
At WordsLinker, we understand the complex process that you have to undergo in regulatory translation, which is why our expert regulatory translators handle all regulatory documents professionally and expertly. To ensure clarity and consistency in the regulatory translation, our subject matter experts pass your regulatory documents through a meticulous and efficient process of translation. After they are done with the translation of your files, these files undergo a quality assessment mechanism where other translators proofread the translated content for any errors. Other than this, our quality assessment process also includes re-assessment and approval from expert translators who have credible experience in the translation of complex regulatory documents.
Why Do Regulation Approval Submissions Need To Be Translated?
Since regulatory documents are of high importance and require extra precision, there is a need to translate these regulatory approval submissions for easy communication. Accurate translation of regulation approval submissions is of utmost importance due to these reasons:
- Regulatory affairs related to approval submissions need to be verified and approved on time by regulatory authorities
- The regulators or regulatory authorities may be present in other countries and may speak different languages, which is why there is a need to translate them accurately
- Translation ensures the regulation approval submissions are understandable, accessible, and comprehensible to all relevant stakeholders, regardless of their linguistic or cultural background
- If not translated properly, regulation approval submission documents can lead to serious consequences such as delays in the regulatory approval process, financial and legal penalties, as well as risks to patient safety.
How to Find A Translator for Regulatory Translator?
The process of regulatory translation is important, requiring accuracy and high levels of professionalism from regulatory translators. WordsLinker provides highly professional subject matter experts with credible experience in delivering professional translations for regulatory files and documents. Our regulatory translators ensure accurate translations of regulatory documents, as they have expertise in technical language and regulatory compliance. They are also capable of editing and proofreading to ensure accuracy in the translations. You can find reliable and professional translators for your regulatory documents by registering your quote on the WordsLinker website, from where our expert regulatory translators will take care of your project and communicate with you about project details and requirements.