Regulatory Affairs Guidance – Dora Wirth Languages | Pharmaceutical Translations https://www.dwlanguages.com Need global life science solutions? Rely on us. Problem solved. Thu, 22 Feb 2018 13:33:50 +0000 en-US hourly 1 https://wordpress.org/?v=4.8.5 What Makes A Good Translation for Regulatory Submission (And How To Avoid Being Let Down) https://www.dwlanguages.com/makes-good-translation-regulatory-submission-avoid-let/ https://www.dwlanguages.com/makes-good-translation-regulatory-submission-avoid-let/#respond Tue, 31 Oct 2017 13:12:52 +0000 http://www.dwlanguages.com/?p=2048 When you’ve worked hard to build your reputation, the last thing you need is your translation service provider letting you down. Without a full understanding of what makes a good translation, selecting your provider can quite literally be a gamble - especially with any extra costs associated with delays to submissions. To take the risk

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When you’ve worked hard to build your reputation, the last thing you need is your translation service provider letting you down. Without a full understanding of what makes a good translation, selecting your provider can quite literally be a gamble - especially with any extra costs associated with delays to submissions. To take the risk out of regulatory translations, we’d like to share the most important factors in ensuring you get a good translation.

First things first - the highest-quality translations for submission to the EMA will always come from a highly qualified, experienced translator with the relevant medical and scientific knowledge. If you find yourself looking to cut costs by sourcing less experienced translators who don’t specialize in translating for the medical/pharmaceutical industry, think twice. Inaccurate and inconsistent translations will cost you far more in the long run. Any rejection of a translated PI at the last hurdle of your MA application not only reflects poorly on your reputation, but there is also the risk to patient safety to consider, should any errors slip through unnoticed. A specialist provider understands the serious implications of any errors or ambiguities, so you can have peace of mind knowing there will be a thorough and extensive quality control process in place.

Secondly, the best translations will come from providers with extensive experience in regulatory processes. All professionals involved in the translation process should have an excellent knowledge of the regulatory framework, documents and procedures. An in-depth understanding of your job means that your provider has a clear and supportive grasp of your needs and expectations, for example knowing when and how to use key terminology. They should demonstrate sound knowledge of the appropriate terminology and regulatory standard text and an awareness of the regulatory timetable and implications of out-of-scope changes to product information during variations or last-minute requests in the 5-day window.

As well as understanding the medical, scientific and regulatory standards and expectations, it is essential for your provider to have linguistic competence in both source and target languages. It really pays to check that your translators are required to translate into their mother tongue only. Translations provided by non-native speakers of the target language are likely to sound stilted, wooden and non-idiomatic, no matter how competent the linguist is. Note that the ISO translation standard 17100 imposes no requirement of using native speakers of the target language, so do check with your language service provider.

No matter how well your linguists rank on linguistic competency and knowledge of the subject matter, let’s not forget that accuracy is of the essence. This includes a faithful translation of the approved core text and consistent style that adheres to the conventions and expectations of the relevant regulatory bodies. Make sure your translation provider has robust and meaningful quality-control measures in place that aren’t relying purely on mechanical tools.

You may think it is fair to assume that all translations are fed into a machine these days, but in fact it is only careful (not universal) use of translation software that can guarantee quality and consistency, when overseen by human professionals with skill and experience in their subject matter.

Finding a service you can truly rely on will give you peace of mind for your submissions (let’s face it, they are stressful enough), making it easy to convince your procurement department of the worthwhile investment.

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Five ways to make your regulatory submission run more smoothly https://www.dwlanguages.com/five-ways-to-make-your-regulatory-submission-run-more-smoothly/ https://www.dwlanguages.com/five-ways-to-make-your-regulatory-submission-run-more-smoothly/#respond Wed, 19 Feb 2014 15:16:33 +0000 http://www.dwlanguages.com/?p=968 As your global partner for regulatory affairs solutions, we at Dora Wirth (Languages) Ltd would like to share some tips to help you prepare your EU regulatory submission.   1. Beat the clock. Your team will have taken great care to produce a high-quality English draft for approval/submission, so please make sure you allow time

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As your global partner for regulatory affairs solutions, we at Dora Wirth (Languages) Ltd would like to share some tips to help you prepare your EU regulatory submission.

 

1. Beat the clock.

Your team will have taken great care to produce a high-quality English draft for approval/submission, so please make sure you allow time for us to provide you with 24 translations of equal quality.

Occasionally DWL will be working right up until your requested deadline, balancing your requirements with those of translators, reviewers and National Competent Authorities (NCAs). Allow us as much time as possible, and read on for more tips that will save you time and money.

2. Document versions: be a control freak.

We have an efficient system in place for reception, processing, delivery and archiving, so it can quickly become apparent if steps have been missed, or if changes have not been recorded within the English source file tracking.

If you regularly work with multiple service providers, don’t assume that we hold the latest version of your reference documents.

3. Give it to us straight.

Our team of professional linguists will adhere very closely to your instructions. The time it takes to administer a change of instructions must be multiplied by the number of languages involved, so take the time to give our project managers the full picture. This includes background information (previous product history, regulatory procedure), QRD versions, tracking IDs, linguistic preferences and reference material. Do you have a point of contact for translator queries?

Aim to communicate your requirements clearly, and be on hand to respond to any translator queries along the way.

4. We like your style.

There are many client preferences when it comes to approaching regulatory submissions at the translation stage. Express up front exactly how we can align with your internal procedures including file naming conventions, liaising with national competent authorities/MS (Member State) reviewers and QRD Form 2 feedback. We will be happy to comply.

Make sure you specify which QRD template we should follow, which file formats you require (e.g. clean/annotated .doc files, bookmarked pdf files), as well as any other information which will help our team tailor the assignment to your needs.

5. Tell us what you really think.

We are constantly seeking to improve our service, and we rely on your feedback to know whether you are truly satisfied.

 

Please get in touch to discuss your requirements, and to find out how we can make your submission process easier.

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